Life Science News

  • Patients taking COMP360 psilocybin with concomitant SSRIs showed comparable treatment outcomes to patients withdrawn from their SSRI therapy in COMPASS's phase IIb trial
  • All patients tolerated COMP360 psilocybin therapy well


London, UK 13 December 2021


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 the results from its exploratory study of COMP360 psilocybin therapy in conjunction with SSRI use. This single-arm open label study of 19 patients taking concomitant SSRI therapy with COMP360 psilocybin therapy using a single dose of 25mg saw comparable treatment outcomes to patients in COMPASS's phase IIb trial where patients were withdrawn from their SSRI prior to COMP360 psilocybin therapy.

"The results of this study challenge the widely-held belief that the use of SSRI medication together with psilocybin could interfere with psilocybin's therapeutic effect. Our findings provide a strong signal that COMP360 psilocybin therapy could be an adjunctive treatment to SSRI antidepressant as well as a monotherapy. For some patients with treatment-resistant depression, withdrawal is a difficult step even though, by definition, ‘treatment-resistant' means that those antidepressants are not working. This is exactly why we conduct rigorous research to help guide our clinical trial design - including addressing barriers to adoption of COMP360 therapy," stated Guy Goodwin, COMPASS Pathways' Chief Medical Officer. "We are now looking forward to meeting with the FDA early in the new year in light of these new data to finalise our plans for the phase III programme, which we expect to begin in Q3 2022."

Study result

This open-label study included 19 patients from clinical sites in Ireland and the United States. The majority of patients were female (68.4%) and the average age was 42 years. The primary endpoint was the change in baseline MADRS 1 total score at 3 weeks in patients having 25mg COMP360 psilocybin therapy given in augmentation with their existing SSRI antidepressant regimen. In the study, 8 of the 19 patients (42.1%) were responders1 at week 3 (compared with 36.7% at week 3 in the phase IIb trial) and all 8 were also remitters1. The mean reduction from baseline observed in MADRS total score was 14.9 at week 3 (compared with a 12.0 mean reduction in MADRS in the phase IIb trial). There was a rapid response from day 2 to week 3 after COMP360 therapy, which is also consistent with the phase IIb result. The baseline MADRS score of patients entering the study was 31.7, representing moderate to severe depression. MADRS scores were assessed by blinded independent raters at baseline, on the day following COMP360 psilocybin therapy, and at weeks 1, 2 and 3. Patients were then invited to participate in COMPASS's long-term follow-up study which also includes patients from the phase IIb trial.

COMP360 psilocybin therapy using a 25mg dose also showed overall signals of improvement in most other measures including improvement in anxiety, clinician and self-rated depressive symptoms, and positive and negative affect.

25mg COMP360 psilocybin therapy was generally well-tolerated when it was administered simultaneously with the patient's SSRI treatment. There were no treatment-emergent adverse events (TEAEs) classed as serious (life threatening, leading to disabilities, hospitalisation or in general medically significant) and no TEAEs related to suicidal ideation or behaviour or intentional self-injury.

COMPASS is now preparing for a meeting with the FDA in early 2022 and this result will be included in that discussion. COMPASS expects to finalise a phase III programme design with the FDA and anticipates commencing that programme in Q3 2022. As a reminder, COMPASS has Breakthrough Therapy designation with the FDA.

-Ends-

Notes to editors:


About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD) 2 , the leading cause of disability worldwide and one of the fastest growing mental health illnesses 3 . About a third of these patients - 100 million people - aren't helped by existing therapies and suffer with treatment-resistant depression (TRD) 4 . As many as 30% of these attempt suicide at least once during their lifetime 5 , 6 . TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients 7 . The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.

 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 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 COMP360 psilocybin therapy as a treatment for depression, 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 business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS's ability to continue to advance its research, including COMP360, COMPASS's expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS's ability to advance new psychedelic compounds in other areas of unmet mental health need. 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 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 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.

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



1 MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10

2 WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]

3 WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]

4 Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.

5 Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367

6 Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63

7 Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23.


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Awakn Life Sciences Files Patent Cooperation Treaty  Application for the Treatment of Behavioral Addictions

Awakn Life Sciences Files Patent Cooperation Treaty Application for the Treatment of Behavioral Addictions

Successful Behavioral Addiction Study Supplied Data for Patent

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company, researching, developing, and commercializing therapeutics to treat addiction, announced today the filing of a Patent Cooperation Treaty (PCT) application for the treatment of behavioral addictions with ketamine and ketamine-assisted psychotherapy. The successful completion of Awakn's behavioral addictions study was announced last week and the data provided from the study was used in the patent filing. The pilot study investigated ketamine as a potential new treatment approach for Gambling Disorder, Internet Gaming Disorder, Compulsive Sexual Behavior Disorder and Binge Eating Disorder.

The PCT covers all behavioral addictions or any recognized disorder or condition with similar compulsive symptoms to those in the study. If granted, the patent claims would give Awakn exclusive rights to use ketamine and ketamine-assisted therapy for the treatment of behavioral addictions. With no effective pharmacological treatments available globally at present for behavioral addictions, the study results and the patent filing position Awakn at the forefront of the industry at a time when rates of behavioral addictions are increasing at an alarming pace and sufferers have few treatment options which deliver poor outcomes.

The promising results from the pilot study showed a reduction of symptoms for some participants, with some participants no longer meeting the criteria for a diagnosis. Some individuals also showed a reduction of the symptoms of a comorbid psychiatric condition, such as depression or anxiety. The treatment was also well tolerated with no safety concerns.

Awakn CEO, Anthony Tennyson, commented, "Today's news demonstrates our focus on researching, developing and commercializing therapeutics to treat addiction. A core part of our efforts is to continually strengthen our IP portfolio as we work to bring effective therapies to chronic addiction sufferers in desperate need. To be forging a path to find an effective treatment for such a vast unmet medical need is critical and an effort we are very proud to be a part of."

Gambling Disorder, Internet Gaming Disorder, and Binge Eating Order are all recognised in the DSM-5, which is a diagnostic tool that serves as the principal authority for psychiatric diagnoses in the US, and affect up to 450 million1, 235 million2 and 100 million3 people respectively. While Compulsive Sexual Behavior Disorder, which is included in the ICD-11, affects up to 350 million4 people. The ICD-11 was developed by the World Health Organization (WHO) and is the global standard for recording health information and causes of death. Current standard of care for all of these conditions is poor.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and commercializing combined therapeutics to treat addiction, with a focus on Alcohol Use Disorder. Awakn's team consists of renowned research experts, world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is working to disrupt this underperforming industry by advancing the next generation of drugs and therapies to be used in combination, through preclinical research and clinical stage trials.

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 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: ROAD Communications
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

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