Posted on

Creso Pharma to enter Swiss medicinal cannabis market

Creso Pharma to enter Swiss medicinal cannabis market

Highlights:

  • Non-binding LOI secured with Innuana AG Switzerland, a licensed cannabis grower to enter the Swiss medicinal cannabis market
  • Innuana will grow medicinal cannabis based on Creso Pharma’s specifications – Creso Pharma to market to doctors and patients
  • LOI has the potential to significantly broaden Creso Pharma’s product offering for the Swiss market, with sales to add to the Company’s growing revenue profile
  • Execution of LOI follows recent Swiss law amendments providing a more favourable operating environment and highlight ongoing acceptance of medicinal cannabis
  • Initial sales focus with oncologists and oncological clinics in Switzerland – Creso Pharma will benefit from established relationships with the medical community over several years
  • Unlocks a large market opportunity for Creso Pharma –expected to be over 110,000 medicinal cannabis patients in 2022i in a market growing to $1.9Bn in value by 2028ii
  • Creso Pharma to leverage established networks with doctors and clinics in the Swiss market to drive growth
  • With the new laws, the commercial export of cannabis for medical purposes will also be permitted providing additional opportunities
  • Expansion of Swiss operations highlights the Company’s broader global scale up

Creso Pharma Limited (ASX: CPH, OTC: COPHF FRA:1X8) (‘Creso Pharma’ or ‘the Company’) is pleased to advise that it secured a non-binding Letter of Intent (“LOI”) with a licenced cannabis grower Innuana AG, Switzerland (“Innuana”) to grow and market medicinal cannabis for the burgeoning
market in Switzerland.

Innuana is focused on the research, growing, processing and production of medicinal grade cannabis. The group has been involved in cannabis cultivation, breeding and research for several years. Innuana has an established reputation in Switzerland and in October 2021, received one of the initial public
orders to grow cannabis by the local government to cover the needs of the City of Zürich in 2022 and beyond.

Both Creso Pharma and Innuana have executed the LOI agreement following recent amendments to the Swiss Narcotics Act in March 2021, which facilitates the patient access for the use of medicinal cannabis in Switzerland.

Following the change of the regulations, the cultivation, processing, production and trade of medicinal cannabis will become subject to the authorisation and control system of the Swiss agency for therapeutic products, Swissmedic. Accordingly, treatment with medicinal cannabis will no longer require an exceptional authorization by FOPH (Federal Office of Public Health)iii.

The legislative shifts will enable Creso Pharma to expand its Swiss operations and enter into the Swiss medicinal cannabis market. Under the LOI, Innuana will grow and produce medicinal cannabis products to the Company’s specifications, which Creso Pharma will sell and distribute to patients.

The initial term of the agreement is one year (“Initial Term”) and will automatically renew after one year (“Renewal Term”), unless either party notifies the other of their decision to not renew the agreement within 30 days prior to the expiry of the Initial or Renewal Term. Initial Term and Renewal
Terms are subject to termination for cause upon notice by either party, or upon failure to meet the above referenced renewal conditions. Should the parties not enter into a formal commercial agreement on or before 30 December 2022, the LOI shall automatically terminate.

Creso Pharma will bring in its medical and pharmaceutical expertise for the growing specifications, and the marketing and use of the product. Creso will also leverage its established relationships with prescribers and clinics in Switzerland to drive prescription sales growth.

Initially, Creso Pharma will focus on the Swiss market, which provides access to a potential 110,000 Swiss patients in 2022i in a market expected to grow to CHF1.3Bn (A$1.9Bn) by 2028ii. Additional expansion efforts into other countries will follow in due course.

Creso Pharma’s Director of International Operations, Mr Jorge Wernli said: “Recent regulatory shifts in Switzerland have unlocked a significant opportunity for Creso Pharma and this collaboration with Innuana marks the first step in our expansion into the Swiss prescription market.

“Healthcare professionals will now be able to prescribe medicinal cannabis products to a large range of patients and importantly this agreement will allow Creso to grow cannabis to its own specifications, utilising pharmaceutical experience and product expertise.

“Initially, we will focus on Switzerland with the medium-term objective to export the products into countries with similar opportunities.”

-Ends-

Authority and Contact Details
This announcement has been authorised for release by the Board of Directors of Creso Pharma Limited.

For further information, please contact:
Investor Enquiries
Creso Pharma Limited
E: info@cresopharma.com
P: +61 (0) 497 571 532
Enquiries can be texted to +61 (0) 497 571 532

Released through:
Ben Jarvis, Six Degrees Investor Relations: Ph: +61 (0) 413 150 448
ABN: 89 609 406 911
Suite 5 CPC, 145 Stirling Highway, | Nedlands, WA, 6009 | Australia
Allmendstrasse 11 | 6310 Steinhausen | Schweiz
CresoPharma.com
(ASX: CPH)

About Creso Pharma
Creso Pharma Limited (ASX:CPH) brings the best of cannabis to better the lives of people and animals. It brings pharmaceutical expertise and methodological rigor to the cannabis world and strives for the
highest quality in its products. It develops cannabis and hemp derived therapeutic, nutraceutical, and life style products with wide patient and consumer reach for human and animal health.

Creso Pharma uses GMP (Good Manufacturing Practice) development and manufacturing standards for its products as a reference of quality excellence with initial product registrations in Switzerland. It has worldwide rights for a number of unique and proprietary innovative delivery technologies which
enhance the bioavailability and absorption of cannabinoids. To learn more please visit:
www.cresopharma.com

About Innuana
Innuana is a GMP grade, licensed cannabis grower based in Switzerland with indoors and outdoors
growing operations. It employs upwards of 20 people and is a subsidiary of Uana Holding AG. In
October 2021, Uana Holding received an order from the city of Zürich to produce cannabis to cover its
needs. Innuana differentiates itself through its extensive strengths and skillset, including

  • Expertise in plant breeding, GMP and medical hemp know-how
  • Existing business as a basis
  • Own and rented fields including cultivation
  • Controlled cultivation areas with all required regulatory approvals
  • Technical expertise
  • Stable core team with unique expertise
  • Outstanding pioneering know-how in SGF 3 (medical cannabis)
  • Leading market recognition

Creso Pharma offices:
Australia
Suite 5 CPC, 145 Stirling Hwy, Nedlands, WA, 6009
Switzerland
Allmendstrasse 11, 6310 Steinhausen, Schweiz
Canada
59 Payzant Driver, Windsor, Nova Scotia, B0N 2TO
Canada
50 Ivey Ln, Windsor, Nova Scotia, B0N 2TO

Forward Looking statements
This announcement contains forward-looking statements with respect to Creso and its respective operations, strategy, investments, financial performance and condition. These statements generally can be identified by use of forward-looking words such as “may”, “will”, “expect”, “estimate”,
“anticipate”, “intends”, “believe” or “continue” or the negative thereof or similar variations. The actual results and performance of Creso could differ materially from those expressed or implied by such statements. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding future expectations. Some important factors that could cause actual results to differ materially from expectations include, among other things, general economic and market factors,
competition and government regulation.

The cautionary statements qualify all forward-looking statements attributable to Creso and persons acting on its behalf. Unless otherwise stated, all forward-looking statements speak only as of the date of this announcement and Creso has no obligation to up-date such statements, except to the extent
required by applicable laws.

i Berner Zeitung: “110’000 patients will soon get cannabis legally”, 18.12.2020
ii Prohibition Partners – The European Cannabis Report: 6th Edition iii Info on the amendments to the Narcotics law in Switzerland, website of the Federal Office of Public Health
(FOPH): https://www.bag.admin.ch/bag/de/home/medizin-und-forschung/heilmittel/med-anwend-cannabis/gesetzesaenderungcannabisarzneimittel.html. The information is available in German, French and Italian: https://www.bag.admin.ch/bag/en/home/gesundleben/sucht-und-gesundheit/cannabis/pilotprojekte.html.

Posted on

MindMed Expands its Drug Development Pipeline with Launch of R(-)-MDMA Program

MindMed Expands its Drug Development Pipeline with Launch of R(-)-MDMA Program

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), (DE: MMQ); the “Company”), a leading biotech company developing psychedelic-inspired therapies, is pleased to announce an expansion of its pipeline with the launch of a program to develop R(-)-MDMA for the treatment of social anxiety and functioning in diagnoses that include Autism Spectrum Disorder (ASD).  This program represents a significant expansion and diversification of MindMed’s pipeline and furthers the Company’s mission to bring innovative products to benefit patients and address unmet medical needs.

Social anxiety and impairments in social functioning are hallmarks of ASD, which occurs in approximately 2% of individuals in the US.  At present, there are no approved therapies for the core symptoms of ASD and there remains a significant unmet need for novel therapies to support people with ASD.  The economic cost of ASD in the US is predicted to reach $461 billion by 2025, highlighting the need and opportunity for novel interventions. Beyond ASD, approximately 12% of the US general population experience Social Anxiety Disorder at some point in their lives, according to the National Institute of Mental Health.

MDMA, which is a racemic mixture of two structurally unique stereoisomers, R(-) and S(+), is currently in development for the treatment of Post-traumatic Stress Disorder (PTSD), and has demonstrated statistically significant positive results in a pivotal Phase 3 trial.  Additionally, in a pilot clinical trial, participants with ASD showed strong and statistically significant improvements in social anxiety and functioning from short-term treatment with MDMA.

The two enantiomers of MDMA each have unique pharmacological activity and preclinical data suggests that the R(-) enantiomer maintains the acute pro-social and empathogenic benefits of racemic MDMA, while demonstrating fewer signs of stimulant activity, neurotoxicity, hyperthermia and abuse liability. This favorable profile suggests that R(-)-MDMA could have applications beyond those of racemic MDMA, including the potential for novel more accessible delivery models and repeat dosing. From a safety perspective, the company has great confidence in the R(-) enantiomer based on its favorable preclinical pharmacology and the extent of prior human dosing of the racemic mixture, which provides valuable insight into the expected safety and tolerability of R(-)-MDMA.

MindMed plans to advance its R(-)-MDMA development program targeting US and EU registration and expects to initiate its first clinical trials in 2022.  As a key initial study, MindMed and the Liechti Lab at University Hospital Basel (UHB) plan to initiate a comparative pharmacokinetics and pharmacodynamic clinical trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in 2022.  This double blind, placebo-controlled, crossover study will assess differences in acute and lasting effects between MDMA and its two enantiomers in healthy subjects and will provide important data on the optimal treatment model for R(-)-MDMA.

MindMed CEO Robert Barrow said, “The launch of our R(-)-MDMA program represents an important milestone in the continued progress of MindMed and builds on our commitment to developing psychedelics and psychedelic-inspired therapies to treat significant unmet medical needs.  The compelling clinical efficacy of MDMA coupled with the unique pharmacological benefits of its R(-) enantiomer suggest that there is an enormous opportunity to bring this second generation psychedelic program to market with the potential for new clinical applications, novel treatment paradigms and enhanced accessibility.”

MindMed Chief Medical Officer, Daniel R Karlin, MD, MA, said, “Our ability to enjoy life has a general dependency on feeling connected to other people, sharing experiences, and conveying shared emotions. There are a number of disorders and conditions, and even varieties of non-pathological states, in which individuals find it difficult to convey their own internal experience and emotions. They also may struggle to recognize the routine cues and signals that those around them use to convey emotions. These difficulties themselves can cause cycles of distressing anxiety, and in turn worsen both the sense, and the reality, of interpersonal disconnect. It is our intention with this new program to offer patients new hope for meaningful connection to the millions of people for whom social anxiety and functioning create day-to-day difficulties.”

About MindMed

MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach of developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the potential of R(-)-MDMA to treat social anxiety and functioning in diagnoses that include ASD and the benefits, safety, applications and plans for advancement and studies with respect to R(-)-MDMA . Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are  available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

Posted on

Seelos Therapeutics Presents a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research

Seelos Therapeutics Presents a Poster on SLS-002 (Intranasal Racemic Ketamine) at the 2021 IASR/AFSP International Summit on Suicide Research

– Data from the Part 1 Open-Label Portion of the Study Demonstrated a Rapid, Robust, and Sustained Improvement on all 4 Scales Utilized Measuring Depression and Suicide

– Data Demonstrated the Group Mean Met the MADRS Responder Criteria at All Times Points Measured from 24 Hours Through Day 29/30 of the Study

– Data Demonstrated the Group Mean Met the MADRS Remission Criteria Initially at Day 6 of the Study

NEW YORK, Oct. 25, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today presented a poster on Part 1, the open-label portion, of the study of SLS-002 (Intranasal Racemic Ketamine) at the IASR/AFSP International Summit on Suicide Research Virtual Conference.

Clinical Improvements in Four Scales over Study Duration in a Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide
Clinical Improvements in Four Scales over Study Duration in a Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide

The poster titled A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with Major Depressive Disorder at Imminent Risk of Suicide, demonstrated rapid, robust and sustained reductions on the Montgomery-Åsberg Depression Rating Scale (MADRS), the Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B), the Patient Global Impression of severity for Suicidal Ideation and Behavior (PGIS-SI/B), and the Sheehan-Suicidality Tracking Scale (S-STS).

“SLS-002 demonstrated a rapid onset of action, impressive efficacy and a sustained improvement from the first dose through the end of the study, including the group mean meeting the MADRS remission criteria initially on Day 6 after only 2 doses,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “Meeting these early criteria for response and remission is highly encouraging considering that these patients were not only severely depressed but also acutely suicidal.”

This open-label portion of the study enrolled 17 subjects diagnosed with major depressive disorder (MDD) requiring psychiatric hospitalization due to significant risk of suicide with a baseline score of > 28 points on the MADRS, a score of 5 or 6 on MADRS Item-10, a score of > 15 points on the S-STS total score and a history of previous suicide attempt(s), as confirmed on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent.

The conference is organized by the International Academy of Suicide Research (IASR) in partnership with the American Foundation for Suicide Prevention (AFSP). 

For additional information: https://suicideresearchsummit.org/

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications (“INDs”). The lead program is focused on the treatment of ASIB in MDD. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 looks to address an unmet need for an efficacious drug to treat suicidality in the United States. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if and when they are effective, it often takes weeks for the full therapeutic effect to be manifested. We believe there is a large opportunity in the United States and European markets for products in this space. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were approximately 1,000,000 visits to emergency rooms for suicide attempts in 2013 in the United States alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for refractory depression and suicidality.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company’s robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), Amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson’s Disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding Seelos’ Phase 2 open label study of efficacy, safety, and tolerability of SLS-002 (Intranasal Racemic Ketamine) in adults with major depressive disorder at imminent risk of suicide (the “Study”), statements regarding SLS-002’s prospects and statements regarding the Company’s potential market opportunity. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing the Study, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Study are not replicated), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com 
https://seelostherapeutics.com/ 
https://twitter.com/seelostx 
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

Related Links

https://seelostherapeutics.com/
Posted on

Autistic children try microdosing at a psychedelic farmer’s market: issue 20

Here’s what’s in store for you in today’s issue:

🍄Autistic children try microdosing

🍄 Group psychedelic therapy cures depression

🍄 Psychedelic farmer’s markets?

🍄 DMT granted innovative medicine designation

🍄 And more.

You’ll want to stay till the end to learn how someone found enlightenment on a trippy hike.

(Did a good friend forward this to you? If so be sure to subscribe here)

Be sure to check out this week’s Daily Mushroom podcast:
The Truth About Psilocybin and the Brain

Julia Joyes is a neuroscientist and research director at TheraPsil, a leading non profit organization making a difference to mental health in Canada. In this episode, we take a closer look at psilocybin’s impact on the brain. 

Therapeutic banner

The first study investigating psilocybin’s impact on children

According to preclinical research conducted by Nova Mentis (NOVA), psilocybin has potential to reduce anxiety in autistic patients and could improve cognitive function in patients with fragile x syndrome (FXS), a genetic condition that causes learning impairments.

Now, the company is forming a joint venture with Mycrodose Therapeutics to accelerate R&D into the treatment. The partnership will use Mycrodose Therapeutics’ patented systems to deliver a self-administered and non-invasive microdose.

The joint venture plans to conduct human clinical trials on a broad range of patients with FXS and autism, including pediatric patients. This will be the first study investigating psilocybin’s impact on children.

Group psychedelic therapy cures depression!

On Tuesday, Compass Pathways (CMPS) received a US patent for COMP360, its proprietary formulation of crystalline psilocybin. On Wednesday, the company announced positive findings from an open-label study using the formulation to treat depression in cancer patients.

Thirty patients were administered COMP360 in group therapy sessions of two to four people. Twenty-four people experienced at least a 50% reduction in depression symptoms within three weeks of treatment, which was sustained at week eight, and fifteen people were in total remission from depression.

The average depression score dropped from 25.9 to just 6.8!

The company notes that the study was not blinded or placebo-controlled, so the findings are subject to expectancy bias, but the results show promise that both COMP360 and group therapy models are effective.

Trip your way to a healthier lifestyle

Psychedelics improve mental health, but can that translate into better physical health too?

A recent study found that people who have tried psychedelics at least once in their life had a 23% lower chance of heart disease and a 12% lower chance of diabetes in the past year.

Other research indicates that psychedelic use is tied to healthier lifestyle choices such as increased exercise, reduced smoking and alcohol consumption, and a balanced diet.

Researchers also theorize that psychedelics could stimulate brain receptors that are linked to both mental and cardiometabolic health.

inspirational banner

DMT receives innovative medicine designation

DMT-assisted therapy could be approved in the UK sooner than expected!

Yesterday, Small Pharma (DMT) received an Innovation Passport Designation for its DMT-assisted therapy program for depression – a status given to promising medicines to expedite development. The passport gives the company access to the Innovative Licensing and Access Pathway (ILAP) to reduce time to market and facilitate patient access to the treatment.

The designation is essentially the UK’s version of a Breakthrough Therapy Designation, which the FDA granted to Compass Pathways (CMPS) and Usona Institute in 2018 and 2019, respectively, for their psilocybin-assisted therapy programs.

Small Pharma also launched a Phase 2a clinical trial for DMT-assisted therapy on Tuesday and began trading on the OTCQB market on Wednesday under the symbol “DMTTF”.

The largest psychedelic event in history

Curious about the latest advancements in psychedelic medicine, psychedelic retreats, microdosing, or the role of technology in the psychedelics sector? Then you won’t want to miss Microdose HQ’s Wonderland: Miami – the largest psychedelic medicine business event to date!

The two-day event on Nov. 8-9 will have keynote presentations from some of the biggest names in the psychedelic sector including including Robin Carhart-Harris, Matthew W. Johnson, Rick Doblin, and David Nutt.

(Mike Tyson and Lamar Odon will also share their experiences with psychedelic healing!)

The speakers will cover a vast range of unique topics: 

  • Shamanic protocols for making investment decisions…
  • Psychedelics and sports…
  • The threat of corporate domination in the industry…
  • And more.

Get your your ticket or virtual access pass here!

business banner

Be an early investor 🤑

Want to be an early investor in a psychedelics company? Now’s your chance!

Ei.Ventures is currently looking to raise $50M through a Regulation A+ Framework – a type of offering that allows the general public, not just institutional or accredited investors, to buy shares in a company before it goes public.

“I’m really passionate about democratizing investment opportunities so any investor can reap the rewards, and take all of the risks of early investment in game-changing companies,” said David Nikzad, the company’s founder, who was an early investor in Airbnb , Betterment, and Vidyard.

Ei.Ventures is developing a transdermal psilocybin patch and is preparing to launch a functional mushroom line early next year. Shares are selling for $4.94 each with a minimum purchase of 101 shares, and the company has already raised $20M. Take advantage of the offer here.

The world’s biggest psychedelic therapy provider

Field Trip Health (FTRP) just got one step closer to reaching its goal of running 75 psychedelic therapy clinics by 2024.

The company opened three new treatment centers in Seattle, Vancouver and Fredericton. It now administers ketamine-assisted therapy at eight clinics across North America and one in Amsterdam.

The treatment is proving to be effective with clients’ depression scores dropping from an average of 17 (severe) to 6 (mild) and benefits lasting at least 120 days.

74 studies on 50 compounds 🤯

This week, Cybin Inc. (CYBN) completed its 74th preclinical study to advance its proprietary molecules, CYB003 and CYB004, toward clinical research.

The company has evaluated 50 novel compounds in its preclinical research, narrowing it down to four lead candidates. including CYB003 for alcohol use disorder and CYB004 for anxiety disorders.

Compared to classic psychedelics, the formulations are showing:

  • Faster onset times
  • Shorter durations
  • High oral bioavailability
  • Significant brain penetration, and
  • Less variability between subjects

Human clinical trials are expected to begin early next year to work toward an Investigational New Drug (IND) status.

legal banner

Psychedelic farmer’s markets coming to Cali!

Oakland could legalize the sale of psychedelics as early as next year!

The city decriminalized the use and cultivation of many psychedelics back in 2019, and now, activists are building on their progress with a “Go Local” Legislative Initiative. The initiative would create a community-based model to allow people to legally purchase natural psychedelics like psilocybin and ayahuasca from local producers.

The initiative will gather research on how best to implement the model over the next year and will introduce a legislation in the summer of 2022.

Some possible reforms being considered include allowing commercial agriculture in residential zones, creating “sacred plant adult farmer’s market permits,” and allowing cannabis dispensaries with 100% local ownership to sell entheogens, among many others.

All products would have to be grown, produced, and tested locally.

Another unanimous win 🎉

After yet another unanimous vote, Easthampton became the fourth city in Massachusetts to decriminalize possession and cultivation of psychedelics!

Will this European island legalize shrooms?

Malta may legalize cannabis, but residents don’t want the reforms to stop there.

In a recent survey, 447 people in Malta were asked if they think the country should legalize any other substances beyond cannabis. Magic mushrooms was the most popular response with 45% in favour of its legalization.

LSD was the next most common response at 27%, but 56% did not see a need for any other drugs to be legalized.

Industry Quick Hits

Oct 18 – Johns Hopkins Receives $4M from the NIH – The First Federal Grant for Psychedelic Research in 50 years Read more…

Oct 19 – FSD Pharma (HUGE) Signs Agreement With Covar Pharmaceuticals To Support The Development Of Lucid-Psych Read more…

Oct 19 – Psyched Wellness (PSYC) says preliminary data reveals potential new functional property of Amanita mushroom for treating skin conditions Read more…

Oct 19 – Bank Of America Shuts Down Account Of Cannabis & Psychedelics Research Institute Registered With DEA Read more…

Oct 19 – atai Life Sciences (ATAI) Launches atai Impact, a Philanthropic Program to Harness the Power of Innovative Mental Health Approaches for Positive Social Change Read more…

Oct 20 – Tryp Therapeutics (TRYP) Reports Clinical Hold on Proposed Phase 2a Study in Eating Disorders Read more… 

Oct 20 – LOVE Pharma (LUV) Announces Development of Muco-Adhesive Sublingual Psilocybin Strip Read more…

Oct 21 – Journal of the Royal Society of Medicine Publishes New COVID-19 Suicide Research Led by Braxia Scientific (BRAX) CEO Dr. Roger McIntyre Read more…

Oct 22 – Novamind (NM) Unveils Stealth Mode Investment in Alto Neuroscience Read more…

Video of the Week

Dr. Bronner’s Support for Psychedelic-Assisted Therapy and Plant Medicines

Playlist of the Week

Lo-Fi | psychedleia
mushrooms on scale
Posted on

Journal of the Royal Society of Medicine Publishes New COVID-19 Suicide Research Led by Braxia Scientific CEO Dr. Roger McIntyre

Journal of the Royal Society of Medicine Publishes New COVID-19 Suicide Research Led by Braxia Scientific CEO Dr. Roger McIntyre

Journal of the Royal Society of Medicine Publishes New COVID-19 Suicide Research Led by Braxia Scientific CEO Dr. Roger McIntyre 

  • Findings Underscore Company Core Objectives to Develop Ketamine Derivatives as Additional Measures to Further Reduce Suicidality

TORONTO, ONTARIO October 21, 2021 – Braxia Scientific Corp. (“Braxia”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, is pleased to announce the publication of a new study led by Braxia Scientific CEO Dr. Roger McIntyre in the Journal of the Royal Society of Medicine.

The publication, entitled “Suicide reduction in Canada during the COVID-19 pandemic: lessons informing national prevention strategies for suicide reduction” was initiated to evaluate the impact of federal, public health and social support programs on national suicide rates in Canada, which were put in place to mitigate the abrupt changes to social and financial provisions brought on by the COVID-19 pandemic.

“Reducing the rate of suicide rates is one of Braxia Scientific’s core objectives and should be a national imperative in Canada and globally,” said Dr. McIntyre. “The findings presented in this research should be used to inform public policy and develop strategies for decreasing suicide rates in Canada.”

The overall suicide mortality rate decreased in Canada from 10.82 deaths per 100,000 in March 2019 – February 2020 (i.e., 4,090 suicide deaths in a population of 37,802,043) to 7.34 per 100,000 (i.e., 2,790 deaths in a population of 38,008,005) in March 2020 – February 2021, an absolute difference of 1,300 suicide deaths. Meanwhile, the Canadian unemployment rate had changed from an average monthly rate of 5.7% in 2019 to 9.5% in 2020. Although the data are provisional, they represent a promising trend.

Coinciding with the reduced rate of suicide in Canada, during the time of observation, there was an increase in the availability of virtual psychiatric healthcare, including but not limited to psychotherapy and counselling service.

“In addition to public policies that prioritize psychiatric services generally, especially for persons at risk for suicide, we believe that we can reduce the rate of suicide even further through the innovative Ketamine treatments we are providing today and through new potential derivatives in the future” added Dr. McIntyre.

“With the current and upcoming clinical trials at Braxia Scientific centers, we are working hard to investigate the effects and potential of psychedelics like ketamine and psilocybin as therapies for treatment-resistant depression and other brain-based disorders that are associated with suicide.”

In addition, the results of the study suggest that government interventions that broadly aim to reduce measures of insecurity (such as those relating to finances, housing and health) and provide timely psychiatric services, should be prioritized as part of a national suicide reduction strategy, not only during but after termination of the COVID-19 pandemic.

The full text of the study can be found here.

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD
“Dr. Roger S. McIntyre”

Dr. Roger S. McIntyre

FOR FURTHER INFORMATION PLEASE CONTACT:
Braxia Scientific Corp.
Tel: 416-762-2138
Email: info@braxiascientific.com
Website: www.braxiascientific.com

The CSE has not reviewed and does not accept responsibility
for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements.

Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

Posted on

The world’s biggest psychedelic therapy provider

Field Trip Health Ltd. Continues Expansion With Psychedelic-Assisted Therapy Centers in Seattle, Vancouver and Fredericton

Field Trip Health (FTRP) just got one step closer to reaching its goal of running 75 psychedelic therapy clinics by 2024.

The company opened three new treatment centers in Seattle, Vancouver and Fredericton. It now administers ketamine-assisted therapy at eight clinics across North America and one in Amsterdam.

The treatment is proving to be effective with clients’ depression scores dropping from an average of 17 (severe) to 6 (mild) and benefits lasting at least 120 days.

PDF of article

Posted on

Field Trip Health Ltd. Continues Expansion With Psychedelic-Assisted Therapy Centers in Seattle, Vancouver and Fredericton

Field Trip Health Ltd. Continues Expansion With Psychedelic-Assisted Therapy Centers in Seattle, Vancouver and Fredericton

With the Opening of Three New Clinics, Field Trip Health Builds Momentum for the Psychedelic Renaissance in the Mental Health Field

TORONTO, Oct. 19, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (NASDAQ: FTRP, TSX: FTRP) (“Field Trip”), a global leader in the development and delivery of psychedelic therapies, announced today the opening of their Seattle clinic, their sixth in the United States, along with the recent opening of a location in Fredericton, NB, and the imminent opening of a location in Vancouver, BC. As the largest provider of psychedelic-assisted therapies globally, Field Trip continues to distinguish itself as a leader in the emerging psychedelic industry with continued expansion and growing demand.

Mental health continues to be a national health crisis as rates of anxiety, depression and PTSD keep climbing. Since opening its first location in March 2020, Field Trip’s ketamine-assisted therapy (KAP) protocols have generated rapid and meaningful improvements for many Field Trip clients as measured by depression and anxiety scales. Based on the data collected to date, Field Trip clients have reported that their depression symptoms improved significantly from “severe” to “mild” on average (with the Mean PHQ9 score of respondents decreasing from 17 to 6), and among respondents such benefits were sustained for 120 days or longer from commencement of treatment. These results suggest that the benefits of Field Trip’s KAP program may compare favorably to ketamine infusions. Each Field Trip Health center is designed to provide an oasis-like setting with elements of nature to give Field Trip clients a space for healing, growth and transformation through psychedelic therapies. The entire experience is supported by Field Trip’s digital technology and tools that guide people through the process from before treatment is approved until after their treatment program is complete, and beyond.

Dr. Ryan Yermus, Field Trip Health’s Chief Clinical Officer, commented: “Since our first clinic opening in Toronto, we have demonstrated the transformative power of our psychedelic-assisted therapy protocols for people struggling with their mental health. As we continue to grow into new markets, the potential to positively change people’s lives is endless. We are incredibly excited to deliver best-in-class psychedelic therapies to the communities in Seattle, Vancouver and Fredericton.”

Hannan Fleiman, Field Trip’s President, added: “Every center opening lays the groundwork for the development of new psychedelic therapies. Not only are we healing the community with the delivery of psychedelic medicine to patients, but we are also ensuring the evolution of the psychedelic reawakening that is happening in the field of mental health.”

The address for the Seattle clinic is 1200 Westlake Ave N Suite 600, Seattle, WA 98109 and people interested in KAP in Seattle can get in touch by phone (1-888-519-6016) or email (seattle@fieldtriphealth.com). The address for the Fredericton clinic is 2398 Lincoln Rd Suite 3, Lincoln, NB E3B 7E6 and people interested in KAP in Fredericton can get in touch by phone (1-833-222-0084) or by email (fredericton@fieldtriphealth.com).

About Field Trip Health Ltd.

Field Trip is the global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics including psilocybin-producing fungi and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967.

Cautionary Note Regarding Forward-Looking Information.

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including patient uptake for ketamine assisted psychotherapy in existing and new clinic locations, interest in the ketamine assisted psychotherapy training program, interest in the KAP Co-Op Program, uptake of the KAP Co-Op Program by therapists and patients, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

Media contacts:

Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-619
press@fieldtriphealth.com

Investor contacts:

Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com
SOURCE Field Trip Health Ltd.

Posted on

Core One Labs Applauds The City Of Seattle In Their Efforts To Decriminalize Psylocibin And Other Natural Occuring Entheogenic Drugs

Core One Labs Applauds The City Of Seattle In Their Efforts To Decriminalize Psylocibin And Other Natural Occuring Entheogenic Drugs

Vancouver, British Columbia, October 16, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABD), (FWB: LD6, WKN: $LD6) (the “Company”) a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy, congratulates Seattle’s city council in their unanimous vote to decriminalize the use, possession and cultivation of naturally occurring entheogenic drugs, including psilocybin for “religious, spiritual, healing or personal growth practices.”.

On Monday, October 4, 2021, the City of Seattle officially became the largest city in the United States to decriminalize non-commercial use around a number of psychedelic substances that originate from “living, fresh, dried or processed plant or fungal material, including teas or powders”, through the passage of resolution number 32021 “A RESOLUTION declaring that the investigation, arrest, and prosecution of anyone engaging in entheogen-related activities should be among the city of Seattle’s lowest law enforcement priorities and stating the council’s support for full decriminalization of these activities.” The resolution was sponsored by City Council member Andrew Lewis, and received unanimous support from all council members, and effectively represents the City’s first step in a move to change its drug policies, and to support the largely demonstrated scientific potential these substances can have in providing cutting-edge treatments for substance abuse and other mental and health afflictions.
Seattle joins at least nine (9) other cities in the United States that have decriminalized psilocybin and similar substances. Other cities include Denver (COL), Washington (DC), Oakland (CA), Santa Cruz (CA), Sommerville (MASS), Cambridge (MASS) and Northampton (MASS) and Ann Arbor (MI). In 2020, the State of Oregon became the first state to legalize psilocybin for therapeutic use.
Another push for the lessening of legal obstacles surrounding psychedelics was made on this month, with the publishing of “Psychedelic therapy: a roadmap for wider acceptance and utilization”, by the head of Harvard Law School’s Project on Psychedelics Law and Regulation, Mason Marks. In a peer reviewed article Mr. Marks advocates for the relaxation of laws around psychedelic drugs in order to further mental health-care innovation. Marks’ article was published in peer-review journal, Nature Medicine, and strongly suggests that the current status of psilocybin, as a Schedule I controlled substance – the same category as hard drugs such as heroin – precludes psychedelics research from receiving federal funding for research, and creates a considerable obstacle to further such research. Mr. Marks stresses that moving psilocybin to a less-restrictive category would help create “more-inclusive clinical trials and unbiased regulatory review” by the U.S. Food and Drug Administration.
“It is very encouraging to see a growing number of governments championing the health and wellness benefits of psychedelics and taking necessary steps towards decriminalization and ultimately de-stigmatization of these beneficial compounds. Additionally, as suggested by Mason in his psychedelic law reform article, eliminating the stigma that currently surrounds psychedelics could go a long way in having these compounds to be rescheduled and exponentially further research efforts.”
The Company further announces that it intends to settle an aggregate of $190,000 in outstanding indebtedness (the “Debt Settlement”) to three arms-length parties through the issuance of 111,112 common shares (the “Shares”) at a price of $1.71 per share. The shares issued under the Debt Settlement will be subject to a hold period of four months and one day from the date of issuance.
The Company also wishes to clarify that, with respect to its upcoming Annual General and Special Meeting of Shareholders scheduled to be held at 11am on October 28, 2021, the deadline to submit proxies is 11:00am on October 26, 2021 (48 hours prior to the meeting).
About Core One Labs Inc.
Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.
ON BEHALF OF THE BOARD OF DIRECTORS OF CORE ONE LABS INC.
Joel Shacker
Chief Executive Officer
FOR FURTHER INFORMATION:
Email: info@core1labs.com
Telephone: 1-866-347-5058
FOLLOW US:
Website: https://core1labs.com/
Twitter: https://twitter.com/Coreonelabs
Facebook: https://www.facebook.com/Core-One-Labs-Inc-100969251278277/
LinkedIn: https://www.linkedin.com/company/core-one-labs
Instagram: https://www.instagram.com/coreonelabsinc/
CAUTIONARY DISCLAIMER STATEMENT:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within a regulatory framework.

Posted on

Health Canada Approves the Use of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Moderate to Severe Atopic Dermatitis

Health Canada Approves the Use of RINVOQ® (upadacitinib) for the Treatment of Adults and Adolescents with Moderate to Severe Atopic Dermatitis

  • Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials evaluating the efficacy and safety or RINVOQ (upadacitinib) in monotherapy or in combination with topical corticosteroids.1
  • RINVOQ demonstrated improvements in skin clearance and itch reduction compared to placebo.
  • Milestone marks the third Health Canada-approved indication for RINVOQ1†

MONTREAL, QC, October 7, 2021 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved RINVOQ® (upadacitinib), an oral, once-daily selective JAK inhibitor for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when
use of those therapies is inadvisable. RINVOQ® can be used with or without topical corticosteroids.”

Atopic dermatitis (AD) is characterized by intense uncontrolled itching, dry skin, which becomes cracked, hardened, oozing and painful. It is estimated that up to 17% of Canadians will suffer from AD at some points in their lives. 2

“Atopic dermatitis is a chronic inflammatory skin disease that impacts both patients and caregivers. As atopic dermatitis is common at all ages, it affects many Canadians. I have seen first-hand the debilitating impact of atopic dermatitis on patients through my research and my practice,” states Dr. Kim Alexander Papp, MD, PhD, FRCPC, Probity Medical Research and K.
Papp Clinical Research, Waterloo ON. “If we hope to improve patients’ overall quality of life, clinicians need more tools. Having access to advanced therapies allows us to better support patients and provide them with treatment outcomes that address their unmet needs.”

The Health Canada authorization is supported by data from a large registrational Phase 3 clinical trial program in atopic dermatitis including more than 2,500 adults and adolescents with moderate to severe disease.1 These multicenter, randomized, double-blind, placebo-controlled registrational clinical trials evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 [MU1] and Measure Up 2 [MU2]) and with topical corticosteroids (AD Up [AU]) compared to placebo.1 3 4 In all three studies, the co-primary endpoints were at least a 75 percent improvement in the Eczema Area and Severity Index (EASI 75) and validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week
16. 1 3 4

Eczema Society of Canada’s Executive Director Amanda Cresswell-Melville highlights the burden of atopic dermatitis. “The impacts of atopic dermatitis on quality of life for both patients and caregivers are often underestimated and misunderstood,” says Cresswell-Melville.

“Patients may be seeking additional options to address their unmet needs in the management of their condition. New treatment options bring hope to these patients.”

Chronic inflammatory skin diseases go well beyond the surface and affect both physical and mental health. The exact cause of atopic dermatitis is unknown, but a combination of immune, genetic, and environmental factors is believed to be involved.3

“AbbVie is dedicated to the pursuit of innovation in life sciences and advancing the standards of care for patients,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

“We are proud of our strong heritage in dermatology and continue to deepen our understanding of the complex nature of serious inflammatory skin conditions. Through this milestone in atopic dermatitis, we remain committed to developing and delivering leading-edge therapies for patients who need them most.”

About RINVOQ® (upadacitinib)
RINVOQ is a once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.
RINVOQ is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable.

RINVOQ can be used with or without topical corticosteroids. For therapeutic and important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.

About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

-30-

1 RINVOQ (upadacitinib) Product Monograph. AbbVie Corporation. Available at
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM_EN.pdf.
2 Canadian Dermatology Association. Eczema https://dermatology.ca/public-patients/skin/eczema/
3 Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-tosevere atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised
controlled phase 3 trials. Lancet. 2021; 397(10290): 2151-2168. doi:10.1016/S0140-6736(21)00588-2.
4 Reich K, Teixeira HD, Bruin-Weller, et al. Safety and efficacy of upadacitinib in combination with topical
corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a
randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10290): 2169-2181.
5 Eczema Society of Canada. What is eczema? https://eczema

Posted on

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

“KET-LID” trial to evaluate ketamine’s safety and efficacy in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease

TORONTO, October 6, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announced today that it has initiated its Phase 2 KET-LID clinical trial of Ketamine for the treatment of Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease. Patient screening and enrollment is expected to begin in October 2021 with data anticipated in late-Q4 2021.The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.  The primary and secondary endpoints are the changes in the following: i) total score of the Unified Dyskinesia Rating Scale (UDysRS), ii) total objective score (III, IV) of the UDysRS, iii) total daily OFF times as assessed by subject- completed 24-hour diaries, and iv) Unified Parkinson’s Disease Rating Scale (UPDRS) total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV.

As previously announced, an IND for the trial has been approved by the FDA.  The Company has completed its clinical trial start-up activities and selection of essential vendors including  project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring.  Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.  

For further detail about the KET-LID trial (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.

If the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.  

“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinson’s disease patients,” said Fabio Chianelli, CEO of PharmaTher.  
There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.

Ketamine’s Potential In Parkinson’s Disease       

Ketamine is an FDA-approved N-methyl-D-aspartate (NMDA) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia (LID) was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.

Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 [360iResearch 2020] and it is estimated that the potential market opportunity for LID Parkinson’s disease to be over USD $3 billion in the U.S. alone.

About Parkinson’s Disease

There is currently no cure for Parkinson’s disease. Although the etiology of Parkinson’s disease is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and Jenner, 2011]. This ultimately affects the cortico-striatal system that controls movement. As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability [Paulson and Stern, 2004]. Also, patients may experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain) [Olanow, et al, 2009]. These non-motor symptoms become more common as the disease progresses. Treatments, including levodopa and dopamine agonists, which restore the dopamine deficits in the brain, have been employed for almost 50 years. However, with continued treatment using levodopa, dose-limiting motor side-effects often emerge. This includes the emergence of abnormal involuntary movements termed Levodopa Induced Dyskinesias, which can be identified in about 50% of patients within five years after initiation of levodopa treatment and in almost all patients within ten years post-treatment initiation. These side effects often limit further dose increases in dopaminergic therapy.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.