PharmaTher (PHRM) was granted a US patent for its formulation of ketamine and betaine anhydrous, a chemical that occurs naturally in the human body and may increase ketamine’s antidepressant effect. The formulation is already patented in Japan and Taiwan, and the company expects to receive patents in Europe, Canada, Israel and China in the near future.
We loved connecting with you all at the Daily Mushroom + Entheon Biomedical Mental Health Town Hall last night 😍 If you couldn’t make it, no worries, we got you. Check out the recording below.
Here’s what’s in store for you in today’s issue:
🍄 A cure for the most annoying Covid symptom?
🍄 Reducing suicidality for 6 months
🍄 Microdosing for withdrawals
🍄 How to prevent bad trips
🍄 And more.
On this very special episode of the Daily Mushroom Podcast, we were lucky enough to be joined by some pretty amazing guests. We had Andy Greenshaw, David Mayoh, Timmothy Ko, Valorie Masuda, Marsha Bennett, and of course our host Brett Higson. We asked our readers to submit questions they had about psychedelics for our knowledgeable board to answer and they did not disappoint! This episode is full of all kinds of insight into the expanding world of psychedelic therapy and what the future may hold.
New research suggests that microdosing doesn’t cause withdrawal symptoms. But can it ease withdrawals from other substances?
MacEwan University researchers found that zebrafish showed increased anxiety behaviour during withdrawal from alcohol, consistent with symptoms that humans experience.
However, when the zebrafish were given microdoses of LSD for 10 days (by putting them in a “dosing tank” for a precise period of time), there were no observed behavioural changes. This indicates that microdosing is not addictive and does not cause withdrawal symptoms.
A study that’s currently underway will examine LSD microdoses on alcohol withdrawal symptoms.
Did you know we share 70% of our genes with zebrafish? Plus, they are extremely social, making them ideal for behavioural studies.
PharmaTher (PHRM) is developing a treatment for a rare, seizure-inducing disorder called Status Epilepticus using ketamine. This week, it was granted a designation that will save them millions of dollars in the process.
It’s called an Orphan Drug Designation and it gives the company potential tax credits, grant eligibility, and marketing exclusivity, and waives a $2.4M New Drug Application fee. It’s designed to incentivize R&D of treatments for rare conditions.
PharmaTher previously received the designation for ketamine to treat ALS and complex regional pain syndrome too!
Even months or years after recovering from Covid, many people have no sense of taste or smell – or worse, everything tastes and smells disgusting.
People are rushing to Reddit and Twitter to share that they’ve finally found a cure: shrooms!
Some report that their senses returned to normal after one dose while others say they were restored gradually over a handful of trips.
Here’s one Reddit user’s experience: “I was shocked and elated.. ran around to find a candle, picked it up, lavender! Began to cry. Began smelling everything in sight. You don’t realize how beautiful it is to smell things, until you can’t smell for almost a year.”
A meta-analysis of 7 clinical trials (5 psilocybin + 2 ayahuasca) found that psychedelic therapy significantly reduced suicidality in as little as 80 minutes.
The significant reductions were sustained for 3-4 months, and patients still had a moderate reduction in suicidality after 6 months.
Entheon Biomedical (ENBI) received approval for a phase I DMT trial and will begin screening patients this month. The trial, which will be conducted in the Netherlands, will gather essential safety and dosing data needed for a phase II study on DMT for nicotine addiction.
Awakn Life Sciences (AWKNF) received a buy rating and a $10 price target from H.C. Wainwright – that’s a 530% increase from its current share price of $1.58 🤑
Lexston Life Sciences (LEXT) received a Section 56 exemption to research psilocybin. It is developing a tool that can rapidly identify and quantify different mushroom compounds such as psilocin, psilocybin, baeocystin, norbaeocystin and aeruginascin.
Tryp Therapeutics (TRYP) announced Q1 financial results including $2.1M in cash and a $3.0M loss for the three months ended November 30, 2021. The company also secured a $2M private placement this week.
An individual in Oregon was issued a patent for a vape pen for “ayahuasca-like substances” including DMT, 5-MeO-DMT, and 2CB. The decision is receiving backlash from many who claim that the technology is not novel and has been around for years.
Tripping can be scary. You never really know how hard a dose will hit you or how long the effects will last — especially if it’s your first time.
What if there was a way to get some insight? Well, there is – HaluGen’s Psychedelic Genetic Test.
With a simple cheek swab, the test tells you:
Use the results to find the dose that’s right for you so you can have the best experience possible!
PharmaTher (PHRM) is developing a treatment for a rare, seizure-inducing disorder called Status Epilepticus using ketamine. This week, it was granted a designation that will save them millions of dollars in the process.
It’s called an Orphan Drug Designation and it gives the company potential tax credits, grant eligibility, and marketing exclusivity, and waives a $2.4M New Drug Application fee. It’s designed to incentivize R&D of treatments for rare conditions.
PharmaTher previously received the designation for ketamine to treat ALS and complex regional pain syndrome too!
IRB approval to initiate Phase 2 study for methamphetamine abuse disorders
Advancing psilocybin oral thin film, microneedle patch and biosynthesis programs
TORONTO, Jan. 17, 2022 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s psilocybin pharmaceutical development programs.
“Revive is building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders. We are embarking on our first clinical study evaluating psilocybin in the treatment of methamphetamine use disorder and advancing the development of an oral psilocybin thin file strip and psilocybin microneedle patch, which will offer flexible therapeutic solutions of psilocybin for unmet medical needs.”
Psilocybin for Methamphetamine Use Disorder
The Company is evaluating psilocybin as a potential treatment for methamphetamine use disorder with the University of Wisconsin-Madison through a clinical trial agreement. Under an investigator-initiated IND, led by Dr.’s Christopher Nicholas and Paul Hutson, the Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder received Institutional Review Board (“IRB”) approval. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in the Company’s proposed oral psilocybin thin film strip. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.
Psilocybin for Stroke
The Company is evaluating psilocybin as a potential treatment for stroke with the University of Wisconsin-Madison. Under the same investigator-initiated IND, led by Dr.’s Christopher Nicholas and Paul Hutson, the proposed Phase I/II clinical study protocol to evaluate the safety and feasibility of psilocybin for stroke is expected to be submitted to the IRB in February. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in the Company’s proposed oral psilocybin thin film strip. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.
Psilocybin Oral Thin Film Strip
The Company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders. Research prototype development is underway to support IND-enabling studies with the expectation to conduct a clinical study in Q4-2022.
Psilocybin Microneedle Patch
The Company entered into a research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM) to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle patch technology for neuropsychiatric disorders. The project plan has been finalized and the Company will initiate IND-enabling studies with the expectation to conduct a clinical study in Q4-2022.
Psilocybin Biosynthesis
The Company is developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University developed by Dr. Gavin Williams, Professor and Researcher at NC State. The biosynthetic platform provides a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli. Certain technical milestones have been achieved to date, offering a clear path towards completing validation methods to demonstrate a novel yet simple production process of biosynthetic psilocybin that can be used at a critical scale for clinical and commercial use. The Company expects to complete a research-grade batch of psilocybin for research in Q2-2022 with the aim to conduct clinical studies in 2023.
Psilocybin International Research
The Company entered into an agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies, including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. Clinical research is expected to begin shortly with the aim for commercialization in 2022 in Antigua and Barbuda. Once approved for sale, the Company will seek commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive 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 Revive 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. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
We’re excited to announce that we’ll be bringing you a FREE virtual event on February 3rd to discuss all things psychedelic and mental health. If your New Year’s resolution is to work on your mental health, you won’t want to miss it! Keep reading for details 😊
Here’s what’s in store for you in today’s issue:
🍄 The most intense psychedelic?
🍄 Impressive findings from a ketamine study on addiction
🍄 A promising treatment for ALS
🍄 Rescheduling psilocybin GLOBALLY
🍄 And more.
On this episode of the Daily Mushroom Podcast, we have Dr. Lyle Oberg, co-founder, and CEO of MYND life sciences. Dr. Oberg has been had an extensive career across many sectors, including working as a family physician and a Chief Policy and Medical Officer at a cannabis company. He was also part of the Alberta government for 15 years as Minister of Finance, Social Services, Learning, and more. Stick around to hear what Dr. Oberg has to say, we are sure it will give a new insight into the world of psychedelics!
Six months after receiving three ketamine infusions and Awakn Life Sciences’ proprietary therapy, 86% of patients with severe alcohol use disorder remained abstinent from alcohol.
Awakn’s study also showed that:
The downside? There isn’t one. There were no serious adverse reactions either 👏
When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found.
Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.
In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease.
The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.
The majority of patients with traumatic brain injury (TBI) also experience depression, and patients with severe TBI-related depression are 5x more likely to attempt suicide.
Wesana Health (WESA) is planning a study to see if the condition can be treated with one large dose of psilocybin in a clinic, followed by “self-administered maintenance doses” of psilocybin and CBD to sustain the benefits.
Researchers believe the treatment will promote neuroplasticity and neurogenesis while reducing neuroinflammation.
Novamind (NM) is hosting a first-of-its-kind study to find out.
The trial will see if ketamine-assisted therapy can enhance the effectiveness of buprenorphine, a first-line addiction medication, in treating opioid use disorder.
Will the two drugs finally be able to conquer this treatment-resistant condition?
We’re collaborating with experts at Entheon Biomedical (ENBI) to bring you a special virtual event on February 3rd.
Here’s what you can expect to learn:
You’ll hear insights and stories from:
Now is your chance to get your questions answered by industry experts and connect with fellow members of the Daily Mushroom Community. We can’t wait to see you there. Register now 👇
“I truly doubt that there is another psychedelic drug, anywhere, that can match [4-HO-DiPT] for speed, intensity, brevity, and sensitive to dose, at least one that is active orally.”
Field Trip Health’s (FTRP) first novel compound could produce the most intense experience of any oral psychedelic.
It’s a more stable and soluble version of 4-HO-DiPT — a drug that induces an extremely powerful experience lasting 2-3 hours, according to Alexander Shulgin, the chemist who created it.
Considering he’s experimented with 55 different psychedelics, which he reviewed in “Tryptamines I Have Known and Loved,” we’ll take his word for it.
Field Trip expects to receive a patent for the formulation next month.
Mydecine (MYCO) is launching a program to sell MDMA and psilocybin, as well as training and support services, to healthcare practitioners through Health Canada’s amended Special Access Program. The company also completed a model that can rapidly screen billions of compounds using AI to find novel psychedelics that bind to serotonin receptors.
Delic Holdings Corp. (DELC) announced that it plans to more than double its footprint in the next 18 months by opening 15 new ketamine clinics, which will be strategically located in secondary cities to improve patient accessibility.
Ketamine One (MEDI) began trading on the OTCQB marketplace under the symbol ‘KONEF’.
atai Life Sciences (ATAI) received FDA approval for a study to investigate how its R-ketamine compound interacts with other drugs.
“Given today’s scientific understanding of psilocybin’s high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue,” according to Christopher Koddermann.
That’s why he co-founded The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) – an initiative that’s pushing for psilocybin to be rescheduled on a global scale.
ITPRI aims to reschedule psilocybin through the United Nations’ Convention on Psychotropic Substances, which was enacted over 50 years ago 😮 This would significantly reduce the regulatory barriers that impede psilocybin research and access to treatment.
So yes, rescheduling is long overdue, but better late than never!
A Missouri Rep. filed a bill to expand the state’s right-to-try law to include psilocybin, MDMA, DMT, ibogaine, LSD, mescaline, and peyote. This would grant patients with serious illnesses legal access to the substances. Read more…
Senator Scott Wiener announced that he is once again pushing for a psychedelic decriminalization bill in California after halting it last year, and believes it has a 50/50 chance of being passed. To generate support, veterans are meeting with Assembly members and changes may be made to possession limits and types of psychedelics included. Read more…
Italian officials verified 630,000 signatures collected in support of a measure to decriminalize cultivation of marijuana and psilocybin mushrooms. If the measure is approved by the Constitutional Court, which will be announced on February 15, it will appear on a ballot this spring. Read more…
Architect David Benjamin wants to make the construction industry more sustainable using (you guessed it) mushrooms!
He constructed a 40-foot-tall structure using bricks grown from mushroom mycelium.
The bricks are lightweight yet durable and can be grown in five days without emitting carbon or producing waste.
When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found.
Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.
In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease.
The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.
Second published study to demonstrate the potential therapeutic utility and mechanism of action of KETABET™ (patented combination of ketamine and betaine) in models of depression
Repeated use of KETABET™ exhibits potential protective and reversing effects on ketamine-elicited psychotomimetic behaviors and cognitive impairments
Supports clinical initiatives as a potential next generation ketamine treatment for mental health and pain disorders with patent protection into 2036TORONTO, January 4, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a life sciences company focused on the development and commercialization of specialty ketamine prescription-based products, today announced the publication of a scientific article demonstrating the potential of KETABET™, a patented combination formulation of FDA-approved ketamine and betaine anhydrous, to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain. The article titled, “Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice”, is published in Biomedicine & Pharmacotherapy and can be found here.
The newly published study further validates the potential of KETABET™ and support the Company’s ongoing investigator-led observational studies evaluating the impact of betaine on the unwanted ketamine side effects seen post ketamine treatment for subjects with either depression or pain. Based on the outcome from the ongoing observational studies, the Company will advance the KETABET™ program with its microneedle patch technology in Phase 2 clinical studies in H2-2022.
Modulation of glutamatergic NMDA receptor by betaine might be the underlying mechanisms accounting for cognitive dysfunction, behavioral deficits, and synaptic neurotransmission induced by chronic ketamine use. The present published study aimed to assess whether repeated co-treatment with betaine and ketamine improved behavioral impairments and hippocampal synaptic plasticity. The experimental results showed that both co-treatment and post-treatment with betaine could exhibit the protective and reversing effects on subchronic ketamine-elicited psychotomimetic behaviors, cognitive impairments, and decreases in synaptic function, LTP, and PSD-95 protein expression. Therefore, betaine may enhance the therapeutic effect when combined or post-treated with ketamine for treatment-resistant depression or other mood disorders, and benefit substance abuse disorders.1
A previously published study revealed that betaine could promote the antidepressant-like effects, yet abolish the psychotomimetic action as well as motor- and cognitive-impairing effects of acute ketamine treatment in mice,2 indicating that betaine might potentially enhance the antidepressant efficacy of ketamine and reduce the acute psychotic symptoms in patients when receive ketamine to treat depression. However, it remained unknown if repeated co-treatment with betaine could minimize the adverse psychiatric effects observed after repeated ketamine use, either medically or recreationally. The present published study supported the repeated use of betaine with ketamine.1
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “The published data demonstrates the potential of KETABET™’s ability to eliminate the unwanted psychomimetic effects and limitations of ketamine, and aims to be a safe and effective at-home treatment option for mental health, neurological and pain disorders. As such, we remain focused on expanding our clinical programs with KETABET™ for FDA approval.”
PharmaTher has an exclusive license agreement with the National Health Research Institutes to develop and commercialize the intellectual portfolio protecting KETABET™, the patent titled “Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine”. Granted patents are issued in Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). In addition, the Company expects to convert the current patent applications in the U.S., Europe, Canada, Israel and China into granted patents. Patent protection is expected to expire in 2036.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine prescription-based products such as KETAPATCH™, a ketamine microneedle patch for mental health and pain disorders, and KETARX™, a ketamine hydrochloride injection USP product for anesthesia, procedural sedation and neurological disorders including Parkinson’s disease and Amyotrophic Lateral Sclerosis. Learn more at PharmaTher.com, 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”, “may” 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 August 31, 2021 (“MD&A”), dated October 27, 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.
References:
Focused on becoming a leader in the development and commercialization of specialty ketamine prescription-based products
Expected milestones for 2022 include initiating Phase 3 clinical study for ketamine to treat Parkinson’s disease (KETLID); completing Phase 2 clinical study for ketamine to treat ALS (KETALS); completing observational study with ketamine and betaine for depression and pain (KETABET); initiating Phase 2 clinical study for ketamine microneedle patch (KETAPATCH); and seeking FDA approval for Ketamine Hydrochloride Injection USPproduct (KETARX)
TORONTO, December 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, is pleased to provide a product pipeline update and expected milestones for 2022.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “2021 proved to be a foundational year for PharmaTher as we achieved a number of milestones which have paved the way for an exciting 2022 in unlocking ketamine’s therapeutic potential for treating Parkinson’s disease and ALS, the development of our ketamine hydrochloride injection USP product and our ketamine microneedle patch as a potential next-generation therapeutic solution for mental health, neurological and pain disorders. We are now in a position both operationally and financially to seek FDA approval for KETARX, our ketamine prescription product, and to enter clinical studies for KETAPATCH, our ketamine patch product, in 2022.”
Project KETLID: Ketamine for Levodopa-Induced Dyskinesia in Parkinson’s Disease
The Company’s Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04912115) to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease is currently ongoing and the Company now expects topline results in Q1-2022. Positive Phase 2 clinical results will allow the Company to 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 by Q3-2022.
PharmaTher has an exclusive license agreement with the University of Arizona for the intellectual property protecting the potential use of ketamine to treat movement disorders. The possible therapeutic effect of low-dose ketamine on 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].
Project KETALS: Ketamine for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease)
An Investigator-initiated IND application has been submitted and it is expected the FDA will accept the IND to proceed to a clinical study for ketamine to treat ALS patients within the next 30 days. Patient enrollment is targeted for Q1-2022. On August 3rd, 2021, the Company was granted orphan drug designation by the FDA for ketamine to treat ALS.
PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS. Ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease. The University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. In addition, unpublished and patent-pending preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.
Project KETABET: Ketamine and Betaine Combination Formulation
The Company is supporting an Investigator-lead observational study to evaluate the impact of betaine anhydrous on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression. The Company now expects results to be reported in early Q1-2022. Based on the results, the Company will advance the KETABET program with its microneedle patch for clinical studies in the H2-2022.
PharmaTher has an exclusive license agreement with the National Health Research Institutes for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine. KETABET has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly. The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine [Lin, Jen-Cheng et al., 2016].
Project KETAPATCH: Ketamine Microneedle Patch
In collaboration with The Queen’s University of Belfast (“QUB”), led by Professor Ryan Donnelly, the Company has successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine and KETABET as a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders. This de-risking milestone supports the Company’s expansion in finalizing IND-enabling studies and the clinical manufacturing scale up with LTS Lohmann, a leader in transdermal delivery systems, to support FDA and international regulatory submissions. Validation and tech transfer activities to support clinical studies are in progress and the Company expects to conduct clinical studies in H2-2022.
PharmaTher has an exclusive license agreement with QUB for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine and psychedelics. Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format [Courtenay, Aaron J et al., 2020].
Project KETARX: Ketamine Prescription (Rx) Product
The Company is developing its own Ketamine Hydrochloride Injection USP product as part of its plans to support the Company’s future Phase 3 clinical studies and its commercialization plans in the U.S. via a supplemental Abbreviated New Drug Application (“sANDA”) with the FDA for use in anesthesia and procedural sedation. The Company expects to file for its sANDA in Q4-2022 for commercialization in the U.S. and international markets thereafter.
PharmaTher has entered into an agreement with Alcami Corporation, a global pharmaceutical contract development and manufacturing organization with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing for the Company’s KETARX project. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications. In addition, the Company will enter the market with KETARX targeting ketamine’s FDA approved label for anesthesia and procedural sedation.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research, development and commercialization of specialty ketamine prescription-based products including KETAPATCH, a ketamine microneedle patch for mental health, neurological and pain disorders, and KETARX, a ketamine hydrochloride injection USP product for anesthesia and procedural sedation. Learn more at PharmaTher.com, 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”, “may” 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 August 31, 2021 (“MD&A”), dated October 27, 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.
TORONTO/ANDERNACH, December 20, 2021 — PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine products, and LTS LOHMANN Therapie-Systeme AG (“LTS”), a leading pharmaceutical technology company, today announced they have entered into a process development agreement for the clinical trial scale up of PharmaTher’s proprietary Ketamine microneedle patch product.
In cooperation with the Queen’s University of Belfast, PharmaTher successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine, a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders. Under the agreement, PharmaTher will cooperate with LTS in the process development and scale up of PharmaTher’s Ketamine microneedle patch product. LTS will be responsible for development and non-commercial manufacturing activities and support PharmaTher’s Investigational New Drug (IND) submission to the FDA in the U.S. and the Investigational Medicinal Product Dossier (IMPD) submission to EMA in the EU. PharmaTher will be responsible for the planning and execution of clinical studies with the Ketamine microneedle patch product.
“We are excited to work with LTS, a leader in transdermal delivery systems, to complete the clinical development of our ketamine microneedle patch product for clinical studies and scale up for future commercial use,” said Fabio Chianelli, CEO of PharmaTher. “With our success in our proof of concept studies in delivering ketamine in our proprietary microneedle patch invivo, we now have a clear development path to unlock the value for ketamine in various unmet medical needs and we are focused on working closely with LTS to produce cGMP ketamine microneedle patches for PharmaTher’s upcoming Phase 1/ 2 clinical studies in 2022.”
Dr. Hanshermann Franke, SVP R&D and Member of the Global Leadership Team commented “LTS is a leading company in microneedle technology and we utilize our expertise, experience and innovation to create drug delivery solutions to improve patient outcomes. The effective treatment of mental illness and neurological disorders are core focus areas for us, and we are pleased to announce this partnership with PharmaTher in the expectation that we can lead the way in this unmet patient need.”
About PharmaTher’s Microneedle Patch
Microneedle-enhanced intradermal delivery is an elegant, efficient and painless method for increasing the skin permeation of many drugs, including ketamine. Transdermal delivery systems offer a number of advantages over inhalation and IV administration. PharmaTher‘s approach consists of a 2-part system comprised of a drug-loaded reservoir that is placed on top of the hydrogel microneedle array. After administration into the skin (i.e. intradermal delivery), the microneedles become hydrated and swell, creating pores for the reservoir to release the drug content into the tissue over the treatment course. Upon removal, the needles are intact, yet rounded, and do not need to be disposed of as sharps. The drug directly enters the systemic circulation, circumventing absorption and first-pass barriers typical for oral delivery. Studies have shown that systemic drug concentrations are reached within minutes after administration and are maintained over multiple days with transdermal delivery. This system addresses a major unmet need by offering greater ease of administration, inclusion of patients with pre-existing conditions that exempt them from oral or inhalation dosing. In addition, it avoids syringe needles, eliminating pain and patient visits to a clinician.
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 advancing 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 and infectious disease treatments. Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
About LTS LOHMANN Therapie-Systeme AG
LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) for the pharmaceutical industry. LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches (MAP) for the transdermal delivery of large molecule, biological actives. Founded in 1984, LTS operates today from two sites in Andernach, Germany and West Caldwell, NJ, USA and a representative office in Shanghai, China.
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
For more information about LTS, please contact:
Dr. Iris Schnitzler
Head of Marketing and Market Services
LTS LOHMANN Therapie-Systeme AG
Email: iris.schnitzler@ltslohmann.com
Website: www.ltslohmann.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”, “may” 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 August 31, 2021 (“MD&A”), dated October 27, 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.
TORONTO, December 14, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering lysergic acid diethylamide (“LSD”). These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with LSD for various indications.
The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver LSD. The research program scope included, full characterization of LSD conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for LSD, and release rate evaluations for the LSD conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA in the future.
The Company’s research program with LSD conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the LSD conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of LSD into microneedles without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.
The Company believes that its MicroDose-MN™ patch for delivering LSD and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”) and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.
The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.
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 advancing 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 and infectious disease treatments.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
For more business development opportunities or 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”, “may” 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 August 31, 2021 (“MD&A”), dated October 27, 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.
