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Multi-centre, d ouble-blind randomised controlled phase II trial will investigate the efficacy of COMP360 psilocybin therap y in anorexia nervosa for which there is currently no approved pharmacological treatment option


London, UK 28 July 2022 COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced it has launched a multi-centre, double-blind randomised controlled phase II clinical trial investigating the efficacy of COMP360 psilocybin, administered with psychological support, in people with anorexia nervosa.

The phase II clinical trial will compare the effects of 25 mg and 1 mg of investigational COMP360 psilocybin when administered with psychological support, in 60 participants with anorexia nervosa, across four world-leading research institutes in the UK and US (King's College London, Columbia University Irving Medical Center, University of California San Diego School of Medicine and Sheppard Pratt). Any changes in symptoms after COMP360 psilocybin therapy will be measured using the Eating Disorder Examination (EDE) interview and other measures; the trial primary endpoint is change from baseline in the EDE global score at week 4 after administration of COMP360 psilocybin therapy.

Anorexia nervosa is a serious mental illness characterised by severe restriction of calorie intake and a preoccupation with weight and shape. Anorexia carries the highest mortality rate (5.86) 1 of all psychiatric disorders because of medical complications and suicide; 2 approximately 20-40% of deaths in anorexia nervosa are thought to result from suicide. 3 Currently there are no approved pharmacological treatments. Globally, about 2.2% of women and 0.3% of men suffer from anorexia nervosa at some point in their lives. 4

In May, COMPASS announced positive early signals from an exploratory, open-label investigator-initiated study conducted by Dr Walter Kaye, Professor of Psychiatry at the University of California San Diego School of Medicine Department of Psychiatry Eating Disorders Program and Principal Investigator on the phase II trial. 5 Dr Kaye said: "Anorexia nervosa is one of the most difficult to treat conditions we face in psychiatry, with the highest suicide rate of any mental health challenge. Not only can it have a huge impact on the people living with it, but also on the people closest to them. Research and progress are urgently needed; we've already seen encouraging data from an exploratory, open-label study in treating anorexia nervosa with COMP360 psilocybin therapy, and this phase II study represents another important step forward."

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said, "There are no approved pharmacological treatment options for people living with anorexia nervosa, and we are determined to change this. We are conducting this rigorous clinical trial to understand whether COMP360 psilocybin, with psychological support, could help people living with anorexia nervosa who urgently need new options."

This will be the first study to use myPathfinder, COMPASS' digital application for supporting patients throughout their COMP360 psilocybin therapy journey. The app is optional for participants in the study, providing engaging education about the therapy model, and with participant consent, collecting real-world data for research on treatment responsiveness. Learn more here .

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About anorexia nervosa

Anorexia nervosa is a serious mental illness characterised by severe restriction of calorie intake and a preoccupation with weight and shape. It carries the highest mortality rate of all psychiatric disorders. 2 This high mortality rate is explained in part by the physical complications (muscle and bone problems, such as osteoporosis; damage to the brain leading to seizures and memory issues; and heart problems including heart failure) and in part by an increased rate of suicide; approximately 20-40% of deaths in anorexia nervosa are thought to result from suicide. 3 Globally, about 2.2% of women and 0.3% of men suffer from anorexia nervosa at some point in their lives. 4

About the COMP360 psilocybin therapy phase II study (COMP401)

The study will recruit 60 participants who currently meet the criteria for either the restrictive or binge-purge subtypes of anorexia nervosa (mild to severe), with a history of disordered eating of at least three years before entering the study and have tried at least one previous treatment in the past three years.

Participants will be randomised in a 2:1 ratio to receive single administration session with either COMP360 25 mg or COMP360 1 mg. Participants will be followed regularly for a period of 12 weeks. During these visits, measures of changes in their psychological symptoms (via structured interviews and self-reported questionnaire) and physical symptoms (via weight measurement) of anorexia nervosa will be performed. Safety assessments will also be carried out to monitor physical and laboratory values and suicidality.

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 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 statement s

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 COMP360 psilocybin therapy as a treatment for depression, anorexia nervosa or any other disease, COMPASS's business strategy and goals, including its ability to obtain regulatory approval of its product candidates, including COMP360, and to launch and commercialise products, COMPASS's ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, and COMPASS's expectations regarding the benefits of its 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 most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission, 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.

Enquiries

Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

References:

1 Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies; Jon Arcelus, Alex J Mitchell, Jackie Wales, Søren Nielsen. Archives of General Psychiatry. https://pubmed.ncbi.nlm.nih.gov/21727255/ . Last accessed: July 2022.
2 Rethinking Therapeutic Strategies for Anorexia Nervosa: Insights From Psychedelic Medicine and Animal Models; Claire J. Foldi, Paul Liknaitzky, Martin Williams, Brian J, Oldfield. Frontiers in Neuroscience. https://www.frontiersin.org/articles/10.3389/fnins.2020.00043/full. Last accessed: July 2022
3 Characteristics of Suicide Attempts in Anorexia and Bulimia Nervosa: A Case–Control Study; Sébastien Guillaume, Isabelle Jaussent, Emilie Olié, Catherine Genty, Jacques Bringer, Philippe Courtet, Ulrike Schmidt. PLOS ONE. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0023578 . Last accessed: July 2022
4 Epidemiology of eating disorders: An update; Anna Keski-Rahkonen, Anu Raevuori, Hans Wijbrand Hoek. https://www.researchgate.net/publication/252793579_Epidemiology_of_eating_disorders_An_update. Last accessed: July 2022.
5 The Safety, Efficacy, and Tolerability of Psilocybin in Participants with Anorexia Nervosa; Stephanie Knatz Peck PhD, Samantha Shao BS, Susan Murray PhD, Walter H. Kaye MD, University of California San Diego School of Medicine, Department of Psychiatry.

Videos accompanying this announcement are available at:

https://www.youtube.com/embed/U3Pp4UQunTo

https://www.youtube.com/embed/1m7srY8HXEM

https://www.youtube.com/embed/BUK3RgjxmpA


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CMPS:US

COMPASS Pathways plc announces second quarter 2022 financial results and business highlights

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Highlights:
  • Kabir Nath appointed as Chief Executive Officer
  • Phase III program submitted to FDA and under review
  • COMP360 phase II study in anorexia nervosa launched
  • Cash position at 30 June 2022 of $207.2 million
  • Conference call today at 8:00am ET (1:00pm UK)

COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the second quarter 2022 and gave an update on recent progress across its business.

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The non-qualified share option was granted on August 1, 2022 and has an exercise price per share equal to $14.94, the closing price of the Company's American Depositary Shares on the Nasdaq Global Select Market on the grant date. The non-qualified share option has a 10-year term and vests as to one-fourth on August 1, 2023 (the first anniversary of his employment commencement date) and as to the remaining three-fourths in equal monthly installments over the following 36 months, subject to Kabir remaining an employee of the Company on the applicable vesting dates. The non-qualified share option has other terms that mirror those of non-qualified share options granted under COMPASS's 2020 Share Option and Incentive Plan and COMPASS's standard form of non-qualified share option agreement.

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  • Canaccord Annual Growth Conference: presentation at 8:30 am ET on 10 August 2022 and host investor meetings

A live audio webcast of each event will be accessible from the "Events" page of the Investors section of the COMPASS website. Each replay of the webcast will be accessible for 30 days following each event. For more information, please visit ir.compasspathways.com.

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Awakn Life Sciences' Phase III Trial Approved for Approximately CA$2.5 Million Funding from UK State Covering 66% of Costs

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Phase III Trial to Cost approximately CA$3.75 million with Awakn's contribution expected to be approximately CA$1.25 million, Marks First Psychedelic Phase III Trial Ever to Receive Government Funding

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announced today that the National Institute for Health and Care Research (NIHR), a UK government agency, has approved grant funding for 66% of the costs of Awakn's Phase III clinical trial exploring the use of ketamine-assisted therapy for the treatment of AUD. The trial is currently forecast to cost approximately CA$3.75 million in total, with Awakn funding approximately CA$1.25 million of that.

The funding will support Awakn's lead clinical development program, Project Kestrel, which aims to deliver clear Intellectual Property (IP) and marketing authorization/regulatory approval for ketamine-assisted therapy to treat AUD in the UK and the US.

The Phase III trial is expected be the largest ketamine-assisted therapy clinical trial to date and the only Phase III psychedelic clinical trial to receive government funding. Awakn will partner with the University of Exeter (UoE) and the UK's National Health Service (NHS) to deliver the landmark trial. It is planned to be conducted across seven sites in the UK, with the treatment being administered within the NHS infrastructure. The trial is currently designed to include 280 patients and they will be followed up over the course of six to 12 months. The trial will also pilot bespoke ongoing peer support groups post-treatment.

The trial, which is targeted to be a pivotal trial, follows on from the ground-breaking results of Awakn's Phase II a/b trial announced in January 2022, which resulted in AUD participants experiencing on average 86% abstinence at six-months post treatment versus 2% pre-trial. The Phase III trial will focus on establishing further definitive evidence of the efficacy of ketamine-assisted therapy for the treatment of AUD and to move towards the novel treatment being licensed for this indication. Awakn, UoE and the NHS will be working with the UK Department of Health and Social Care and other key stakeholders throughout the trial to facilitate the swift uptake within the NHS post trial, should the results be positive.

The Phase III trial will be led by Professor Celia Morgan, Awakn's Head of Ketamine-Assisted Therapy and Professor of Psychopharmacology at the University of Exeter.

Professor Morgan commented: "It is a true honour to lead the team that will deliver this research. The trial represents a huge leap forward in the treatment of AUD. I know this will be a great source of hope for the patients we work with, their families and friends. The financial commitment by the UK Government emphasises the promise of this treatment and the scientific rigour behind the trial. This, coupled with running the trial in the NHS settings and working closely with regulators throughout, means that the probability of quick adoption is very high, should the results of this trial fulfil their early promise."

Awakn selected AUD as its lead indication because it is a chronic disease constrained by a significant treatment gap, and a poor current standard of care. AUD affects 400 million[1] people globally; with only 8% of people with this disease seeking treatment[2], and typically a 75% relapse rate within 12 months among those who have[3]. Despite this significant treatment gap and poor efficacy, the US AUD treatment market is valued at CA$45 billion[4], while the NHS in the UK spends more than CA$5.5 billion a year[5] on AUD related illness.

Anthony Tennyson, Awakn's CEO commented:"We are pleased with today's news for several reasons. A government showing such strong support for this new type of treatment is a global first. Secondly, working with the NHS to deliver the treatment in their existing infrastructure is a huge statement of intent, but most importantly, for so many millions of people around the world suffering from alcohol addiction, a new treatment hope has just got one big 'step' closer. I could not be prouder of the Awakn team and our partners for making this a reality."

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat substance and behavioral addictions. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting 400m people globally for which the current standard of care is inadequate. Our goal is to provide effective therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels.

www.AwaknLifeSciences.com | Twitter | LinkedIn | Facebook | www.AwaknClinics.com

About Project Kestrel

Project Kestrel is the lead clinical development program of Awakn Life Sciences. Project Kestrel is supported by Awakn's Phase II a/b 'KARE' clinical trial which examined ketamine-assisted therapy for the treatment of Alcohol Use Disorder (AUD). The trial resulted in patients experiencing on average 86% abstinence at 6 months post treatment versus 2% before the trial which means that study participants went from being sober on average 7 days a year to being sober on average 314 days a year. Awakn is planning to initiate a Phase III trial in the UK in 2022 and plans to seek regulatory approval in the UK and the US in due course.

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 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, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; 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; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; 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:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com

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

Rest of World: Eat More Fruit Communications
Paul Jarman / Nora Popova
awakn@eatmorefruit.com

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