Posted on

COMPASS Pathways and partners launch The Centre for Mental Health Research and Innovation, in the UK

COMPASS Pathways and partners launch The Centre for Mental Health Research and Innovation, in the UK

Pioneering collaboration with King’s College London and South London and Maudsley NHS Foundation Trust

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has formed a long-term strategic partnership to launch The Centre for Mental Health Research and Innovation (“the Centre”) to accelerate psychedelic research and develop new models of care for mental health in the UK.

Together with South London and Maudsley NHS Foundation Trust (SLaM), the largest mental health trust in the UK National Health Service (NHS) and the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London, this pioneering collaboration will provide patient access to cutting edge research studies in multiple areas of high unmet need in mental health.

The Centre will accelerate research of emerging psychedelic therapies, support therapist training and certification, evaluate real-world evidence, and prototype digital technologies to enable personalised, predictive and preventative care models.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “In 2021, the UK Government included mental health care as a core pillar of its Life Sciences Vision – a signal of how critical an issue this is becoming. We are grateful to be able to play a part in this, and to be working with SLaM and the IoPPN, UK leaders in patient care and research in mental health. The Centre will accelerate the integration of innovative psychedelic therapies into the NHS following regulatory approval and reimbursement. It is a key part of our strategy to work with health systems to develop innovative evidence-based therapies, and ensure they reach those who might benefit from them as quickly as possible.”

Research will initially focus on COMPASS’s investigational COMP360 psilocybin therapy and supportive technologies, and will also cover other novel therapeutic approaches being researched and developed by COMPASS, in areas of significant unmet mental health need including treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD) and anorexia nervosa.

The ambition is for the Centre to be a beacon of innovative mental health care models, and help inspire and accelerate the development of such public-private partnerships among industry sponsors, academic investigators and the NHS under the Mental Health Mission within the new UK Government Life Sciences Vision. The Centre will initially be located at Maudsley Hospital, London, while state-of-the-art facilities are built within a 200 acre woodland at Bethlem Royal Hospital, London. This dedicated and purpose-built space for late-stage clinical trials will be managed by leading clinical investigators with extensive experience in conducting psychedelic clinical trials, and will provide access to COMP360 psilocybin therapy to an estimated 650-700 patients over a five-year term.

David Bradley, Chief Executive of South London and Maudsley NHS Foundation Trust, said, “We are seeing a rapid growth in the number of people with mental health care needs, in South London and across the UK. We are proud to continue our legacy of innovation and research by partnering with COMPASS Pathways to directly translate research into healthcare treatment and significantly improve care in our communities.”

Professor Allan Young, Head of Academic Psychiatry at King’s IoPPN, said, “This new Centre is all about putting patients first. The collaboration with COMPASS Pathways will focus on developing new and effective therapies, as well as considering the patient experience in the real world. We hope it will pave the way for how research and innovations partnerships are developed in the future.”

-Ends-

About COMPASS Pathways    

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of psilocybin therapy, including COMP360, as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s expectations and plans regarding the Centre, COMPASS’s expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, and COMPASS’s expectations regarding the benefits of psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

About King’s College London and the Institute of Psychiatry, Psychology & Neuroscience

King’s College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and 8,500 staff. King’s has an outstanding reputation for world-class teaching and cutting-edge research. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain.

www.kcl.ac.uk/ioppn @KingsIoPPN

About South London and Maudsley NHS Foundation Trust

South London and Maudsley NHS Foundation Trust is a large and complex multi-site provider of mental health services – providing the widest range of NHS mental health services in the UK. We aim to make a difference to people’s lives by seeking excellence in all areas of mental health and wellbeing. Our 6,000 staff serve a local population of 1.3 million people and we offer more than 260 services including inpatient wards, outpatient and community services across Lambeth, Lewisham, Southwark and Croydon. We also provide substance misuse services for people who are addicted to drugs and alcohol. As well as serving the communities of south London, we provide more than 20 specialist services for children and adults across the UK including perinatal services, eating disorders, psychosis and autism.

Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

Posted on

Why the UK is becoming a psychedelic hotspot

Brexit Britain becomes unlikely psychedelic haven as Albert Labs IPOs

The UK is on a mission to create a world-leading clinical research ecosystem that’s more efficient and effective than ever before – and many psychedelic companies are taking advantage of the regulatory changes.

To reach this goal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) now allows “real world data” (data collected from patients and healthcare systems outside of clinical trials) to aid in the drug approval process

This may bring psychedelic therapies to market much faster not only in the UK, but also in Australia, Canada, Singapore and Switzerland, as the MHRA joined a coalition with these countries called the Access Consortium.

Additionally, the UK may reschedule psilocybin to Schedule 2, reducing barriers to clinical research.

Just yesterday, COMPASS Pathways (CMPS) announced a strategic partnership to launch a major psychedelic research center in the UK.

Other companies to keep an eye on that may benefit from these changes include Albert Labs (ABRT), Awakn Life Sciences (AWKN), Small Pharma (DMT), Beckley Psytech, Eleusis.

PDF of article

PDF of article 2

Posted on

MAPS receives Innovation Passport for MDMA therapy 🎉

MAPS is Granted Innovation Passport in United Kingdom for MDMA as an Adjunct to Therapy for PTSD

The Innovation Passport will make MDMA therapy for PTSD widely available in the UK, as rapidly as possible!

The Multidisciplinary Association for Psychedelic Studies (MAPS) found that 88% of patients had a reduction in PTSD symptoms after three MDMA sessions in conjunction with trauma-focused therapy. 

The organization was granted an Innovation Passport for the treatment – a UK designation that speeds up the timeline for approval of innovative medicines for life-threatening conditions (similar to Breakthrough Therapy Designations in the US, which the treatment received in 2017).

Multidisciplinary Association for Psychedelic Studies – MAPS

PDF of article

Posted on

MHRA Guidance on the use of Real-World Data in Clinical Studies for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway

MHRA Guidance on the use of Real-World Data in Clinical Studies for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway

JANUARY 4, 2022 – VANCOUVER, BRITISH COLUMBIA

On the 17th December 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) produced guidance acknowledging and setting out the criteria for the use of Real World Data and Evidence in regulatory decision making. This guidance is consistent with Albert Labs’ strategy, one of the first psychedelic drug development companies to use a Real World Evidence (RWE) approach for regulatory approval.

Albert Labs is pursuing the RWE pathway in the licensing of their natural psilocybin medicine, which has been endorsed by leading hospital centers in the UK. This expedited pathway offered by the UK regulatory system will accelerate access to treatment, benefiting patients not only in the UK but the rest of Europe, Canada, and the US.

“We embrace this regulatory guidance particularly in the investigation of psilocybin-assisted psychotherapy. Albert Labs consider that carefully designed pragmatic trials that implement a progressive use of Real World Evidence, will greatly advance the understanding of the safety, effectiveness, impact, and optimal clinical use of this new therapy.,” said Dr. Malcolm Barratt-Johnson, the Chief Medical Officer of Albert Labs.

The guidance emphasizes that a study or studies considered under this RWE approach, need to be of the same standard as would be expected from a traditional Randomized Control Trial (RCT). The guidance further states that well-designed and conducted prospective RCTs provide a high level of evidence irrespective of the categorization of the data source.

“Our approach, in the investigation of psilocybin-assisted therapy, has been designed to reduce risk, improve outcomes, and importantly to speed up access to those patients who will benefit from this therapy. We believe Real World Evidence will play a vital role in helping safeguard the development of this promising mental health treatment,” added Dr. Malcolm Barratt-Johnson.

Albert Labs, in following the MHRA’s guidance is taking the necessary regulatory and clinical steps required for authorization of a new treatment using an RWE approach. The trials are focused on early access to treatment. Albert Labs expects to treat patients suffering from cancer-related distress in the first half of 2022 with this focused approach and accelerated product development and licensing pathway.

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs Inc.

Dr Michael Raymont

Chief Executive Officer

_______________________

About Albert Labs Inc.

A laboratory-based, clinical research and drug development enterprise. Albert Labs and its team are experts at the production and extraction of natural compounds and creating licensed medicines. Through a succinct clinical pathway, focusing on Real World Evidence (RWE) Albert Labs will initially look to commercialize its mycelium-based KRN-101 medicine & treatment, and in doing so deliver psychedelic-assisted psychotherapy to patients sooner. Focused on accelerating access and faster approvals, Albert Labs put patients with urgent and unmet needs first as it develops licensed medicines to treat a variety of mental health conditions. Cancer-related distress, an initial focus of Albert Labs development program is thought to affect over 1 million patients in the UK.

[1] Read the MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions here. 

Listen to Albert Labs’ Chief Medical Officer, Dr. Malcolm Barratt-Johnson introduce Albert Labs and their mission here.

Watch a short “About Albert Labs” video and hear more of the investment opportunity here._______________________

Cautionary Statement

This news release includes forward looking statements that are subject to assumptions, risks and uncertainties.  Statements in this news release which are not purely historical are forward looking statements, including without limitation any statements concerning the Company’s intentions, plans, estimates, beliefs or expectations regarding the future.  Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate.

The Company cautions readers that all forward looking statements, including without limitation those relating to the Company’s future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward looking statements.  Readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance on forward looking statements.

Any forward looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward looking statements, or to update the reasons why actual events or results could or do differ from those projected in the forward looking statements.  The Company assumes no obligations to update any forward looking statements, whether as a result of new information, future events or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs Inc.

For further information: Email: press@albertlabs.com.i

Posted on

Pasithea Therapeutics Opens Second Ketamine Therapy Clinic in the United Kingdom

Pasithea Therapeutics Opens Second Ketamine Therapy Clinic in the United Kingdom

— Expanding Pasithea Clinics footprint in London —

MIAMI BEACH, Fla., Dec. 21, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, has opened its second London clinic in Marylebone offering intravenous (“IV”) ketamine therapy to patients suffering from treatment-resistant mental health issues. The Company opened its first U.K. clinic in Knightsbridge in October 2021.

“Through our second London clinic, we are pleased to increase access to this important therapy for patients in the U.K. with treatment-resistant mental health disorders,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics. “More than ever, new treatment therapies are urgently needed for these patients and by broadening our coverage, we can work to close the treatment gap.”

“Two decades of research supports the efficacy of ketamine in improving symptoms experienced in some mental health disorders. With the opening of our Marylebone location, we are expanding our footprint in the U.K. and will continue to work toward bringing this treatment option to patients nationwide,” said Dr. Yassine Bendiabdallah, Managing Director of Pasithea Clinics in the U.K.

Ketamine is a U.S. Food and Drug Administration (“FDA”) approved drug introduced to the medical community as an anesthetic more than 50 years ago. It has recently been repurposed for the treatment of psychiatric disorders using significantly lower doses than in anesthesia and is gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect.

Major Depression is the leading cause of long-term disability worldwide, according to the World Health Organization, with existing treatments having limited success rates, numerous side effects and onset of action delayed by several weeks. Studies have shown that up to 70% of those who receive IV ketamine treatment can eventually show a clinical response. While the number of treatments suggested is done on a case-by-case basis, a typical treatment plan consists of up to six infusions in the interval of two to three weeks.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Pasithea Therapeutics Corp. Company Contact
Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com

Pasithea Therapeutics Corp. Investor Relations
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Primary Logo

Source: Pasithea

Released December 21, 2021

Posted on

New guidelines in UK could accelerate clinical trials

MHRA’s new guidance on using real-world data to support clinical trials could get medicines to patients sooner

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) changed its guidelines to allow the use of “real-world data” collected from the healthcare system to aid in regulatory approval of new medicines. This will expedite clinical trials and get treatments to patients sooner!

PDF of article

Posted on

Cybin Confirms Scientific Advice Meeting with UK Medical and Healthcare Products Regulatory Agency for Lead Candidate CYB003 for the Treatment of Major Depressive Disorder and Alcohol Use Disorder

Cybin Confirms Scientific Advice Meeting with UK Medical and Healthcare Products Regulatory Agency for Lead Candidate CYB003 for the Treatment of Major Depressive Disorder and Alcohol Use Disorder

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™” is pleased to announce that it has confirmed a scientific advice meeting with the UK Medical and Healthcare Products Regulatory Agency (“MHRA”) for the first quarter of calendar year 2022. This program milestone brings the Company closer toward advancing its lead investigational candidate CYB003 into clinical development for the treatment of major depressive disorder (“MDD”) and alcohol use disorder (“AUD”).

“Encouraged by positive preclinical findings that demonstrated the advantages of our novel deuterated psilocybin analog over oral psilocybin for the treatment of mental health, we are moving rapidly to progress CYB003 toward clinical development. We are looking forward to engaging with the MHRA to determine next steps for our clinical development path evaluating CYB003 for the treatment of MDD and AUD in the UK,” said Doug Drysdale, Chief Executive Officer of Cybin.

“CYB003 was designed to address the shortcomings of existing treatments, while retaining the therapeutic benefits of oral psilocybin. We believe that CYB003 has the potential to achieve better patient outcomes, including less variability, faster onset of action, shorter duration of effect, and improved brain penetration. As a society, we need to prioritize the treatment of mental health, and Cybin is committed to taking these next important steps toward progressing psychedelics to therapeutics,” concluded Drysdale.

On November 8, 2021, the Company reported preclinical data for CYB003 demonstrating:

  • a 50% reduction in variability compared to oral psilocybin; indicates potential for more accurate dosing in patients with MDD and AUD;
  • a 50% reduction in dose compared to oral psilocybin; indicates potential to maintain equivalent efficacy while reducing side effects, such as nausea, in patients with MDD and AUD;
  • a 50% shorter time to onset when compared to oral psilocybin; indicates potential for shorter duration of treatment, lower inter-subject variability, better therapeutic control and safety, leading to a better patient experience, with lower cost and scalability; and
  • nearly double brain penetration when compared to oral psilocybin; indicates potential for a less variable treatment response, a lower dose therapeutic effect, and reduced patient side effects.

The Company plans to file a clinical trial application with the MHRA in the second quarter of calendar year 2022.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics™ by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended September 30, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

Posted on

Treating alcoholism in Europe

Awakn Life Sciences Signs MOU with NHS (Devon Partnership NHS Trust) and University of Exeter with a View of Increasing Access to Psychedelic-Assisted Psychotherapy in the UK

Last year, Awakn Life Sciences (AWKN) found that MDMA-assisted therapy helped alcoholics reduce alcohol consumption by 85% – from an average of 130.6 units per week to just 18.7. Now, the company is exploring a partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) to treat alcohol use disorder across Europe, where alcohol is one of the top five causes of disease and disability in most countries. Awakn may license MAPS’ pre-clinical data to get the treatment to market faster.
logo
PDF of article
Posted on

Awakn Life Sciences Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry

Awakn Life Sciences Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry

Worlds’s First Controlled Study To Investigate Ketamine-Assisted Psychotherapy

TORONTO, CANADA, November 4, 2021 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, announced today that the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention study, which was the first controlled study in the world to investigate ketamine-assisted psychotherapy, will be published in the American Journal of Psychiatry later this year. The study was conducted by University of Exeter (UoE) and led by Prof. Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-assisted psychotherapy for addiction. Awkan has acquired the rights to this research.

The findings, which will be shared in detail in the journal, are a very exciting step forward in the treatment of alcohol use disorder and for the wider psychedelic industry in general. The phase II a/b trial had four groups, ketamine with and without therapy, and placebo administered with and without therapy.

Professor Morgan commented “We are delighted that the findings are to be published in the American Journal of Psychiatry. This new approach looks set to revolutionise the treatment of alcohol use disorder. We are excited to partner with Awakn for the next steps in the journey of ketamine-assisted therapy into a licensed treatment for this group of patients with limited treatment options.”

With ketamine already a licenced medicine, the phase II a/b results allow Awakn to deliver the KARE treatment in its clinics in the UK and Europe immediately and through its licencing partnerships outside of these territories. The University of Exeter and Awakn are investigating how best to move this research forward to a pivotal phase III trial, which ultimately would allow it to be delivered ‘on label’, meaning it could be adopted by public health systems and covered by insurers.

Following the study, Dr. Morgan’s research team also interviewed participants in the trial and published an analysis of their experiences in the journal Frontiers in Psychiatry entitled, “This Is Something That Changed My Life: A Qualitative Study of Patients’ Experiences.” A brief selection of quotes from the paper below, show the life-changing effect the treatment had on them and crucially how it changed their relationship with alcohol.

It helped family wise, relationship wise, in every, every single avenue of my life, It’s changed it.

I wouldn’t be here now if it wasn’t for it. I can definitely say that.

I feel I have much less desire to drink now than I used to. And I think what it is, I actually, I think I enjoy it less now”

“I think before the trial all my life was sort of focused around alcohol. I was either drinking it at home or selling it to students or working in an event where there was alcohol, the alcohol was a focus of it. So it was sort of everything and then afterwards, it just sort of stopped.

Chief Executive Officer of Awakn, Anthony Tennyson commented; “This is a very exciting moment for ketamine-assisted psychotherapy. For so many people who are suffering from alcohol addiction, for whom the current treatments just aren’t working, a successful phase II a/b trial and a unified ambition to progress this forward to a pivotal trial, gives real hope to those seeking a better and healthier future.”

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (medicines and therapies) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will deliver these evidence backed psychedelic therapies in clinics in the UK and Europe and through licensing partnerships globally.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World:
ROAD Communications
Paul Jarman / Anna Ramsey

Awakn@roadcommunications.co.uk