Greatest randomised, managed, double-blind psilocybin remedy examine ever accomplished
shows swift and sustained reaction for clients receiving a single dose of COMP360 psilocybin
with psychological guidance
COMPASS management group to host an investor conference connect with currently at 1.00pm Uk (8.00am ET)
London, United kingdom – 9 November 2021
COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care business focused to accelerating patient accessibility to evidence-primarily based innovation in mental overall health, now introduced that its groundbreaking stage IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant melancholy has attained its key endpoint for the greatest dose, with a 25mg dose of COMP360 demonstrating a really statistically major and clinically related reduction in depressive symptom severity following three weeks, with a rapid and strong therapy reaction*.
In the randomised, managed, double-blind trial, a one dose of investigational COMP360 psilocybin was offered to 233 sufferers in conjunction with psychological assistance from specifically experienced therapists. All individuals discontinued antidepressants prior to participation. The trial was run to look at two energetic doses of COMP360, 25mg and 10mg, versus a comparator 1mg dose. The 25mg team vs the 1mg group confirmed a -6.6 distinction on the MADRS* depression scale at 7 days 3 (p<0.001). The 25mg group demonstrated statistical significance on the MADRS efficacy endpoint on the day after the COMP360 psilocybin administration (p=0.002). The 10mg vs 1mg dose did not show a statistically significant difference at week 3. The MADRS was assessed by independent raters who were remote from the trial site, and blind to intervention and study design, effectively creating a triple blind.
At least twice the number of patients in the 25mg group showed response and remission* at week 3 and week 12, compared with the 1mg group. The protocol-defined sustained response* up to week 12 was double, with 20.3% of patients in the 25mg group vs 10.1% in the 1mg group. Using a definition of sustained response* that is consistent with other TRD studies, the difference was more than double, with 24.1% of patients in the 25mg group vs 10.1% in the 1mg group.
COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) being mild or moderate in severity. 179 patients reported at least one TEAE the most common TEAEs across treatment groups (>10% total incidence) were being headache, nausea, fatigue and sleeplessness. There were being 12 sufferers who documented treatment method-emergent critical adverse activities (TESAEs). These TESAEs incorporated suicidal behaviour, intentional self-injuries, and suicidal ideation, which are routinely noticed in a cure-resistant melancholy affected individual population, and which occurred extra routinely in the 25mg group than in the 10mg or 1 mg teams. Total, 209 patients accomplished the review there were 5 withdrawals from the 25mg group, 9 from the 10mg, and 10 from the 1mg.
This randomised, controlled, multicentre, double-blind period IIb trial is the greatest psilocybin treatment medical trial ever done, with 233 sufferers from 10 countries in North America and Europe. 94% of the people had no prior encounter with psilocybin. The aim of the demo was to uncover the acceptable dose for a larger sized, pivotal stage III programme, which COMPASS expects to get started in 2022.
Despair that is not assisted soon after two or far more sufficient antidepressive solutions is referred to as remedy-resistant despair (TRD)1,2. Much more than 100 million persons around the world are influenced by TRD1,2, and as numerous as 30% of these try suicide at the very least at the time during their life time3,4. The TRD population is by definition far more complicated to handle and more likely to relapse than people with important depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin treatment for TRD.
George Goldsmith, CEO and Co-founder, COMPASS Pathways, stated: “No one is untouched by the psychological well being crisis – anyone has a story. We urgently need choices for persons who are not assisted by current therapies. We set out to investigate the safety and efficacy of COMP360 psilocybin therapy in cure-resistant despair, as a result of a arduous and massive-scale trial, and to locate an ideal dose to take to the up coming phase. I am delighted that we have succeeded in executing this. We have shown our potential to execute an impressive, multicentre, multinational medical trial programme – and in the midst of a international pandemic. Our function follows the endeavours and achievements of so numerous researchers ahead of us, and we are grateful to all of them and for the opportunity to work with the psychological wellbeing care community to renovate individual experience and individual results. With our world-top psychedelic investigate more than the very last couple of a long time, we have now established a unique and extensive knowledge lake this offers an unprecedented prospect to further more evaluate and optimise psilocybin therapy for sufferers struggling with significant mental health and fitness sickness. With these powerful data, we will urgently development our clinical progress programme and move nearer to generating this therapy accessible to individuals in have to have, if permitted.”
- COMP360 25mg vs 1mg: a distinction of -6.6 factors in adjust from baseline in MADRS overall scores at 7 days 3 (p<0.001), with a statistically significant difference seen from day 2 up to week 6
- COMP360 10mg vs 1mg: a non-statistically significant numerical treatment difference of -2.5 points at week 3 (p=0.184)
- At least double the number of MADRS responders, remitters, and sustained responders with 25mg vs 1mg rapid response and remission from day 2 to week 3
- 36.7% (29 patients) in 25mg group showed response at week 3, compared with 17.7% (14 patients) in 1mg group
- 29.1% (23 patients) in 25mg group were in remission at week 3, compared with 7.6% (6 patients) in 1mg group
- 24.1% (19 patients) in 25mg group were sustained responders at week 12, compared with 10.1% (8 patients) in 1mg group
- COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) mild or moderate in severity
- Treatment-emergent adverse event (TEAE) incidence
- 83.5% (66 patients) in 25mg group
- 74.7% (56 patients) in 10 mg group
- 72.2% (57 patients) in 1 mg group
- Treatment-emergency serious adverse event (TESAE) incidence
- 6.3% (5 patients) in 25mg group
- 8.0% (6 patients) in 10 mg group
- 1.3% (1 patient) in 1mg group
David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is a common and devastating condition, affecting tens of millions of people, with few effective treatments. This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD. In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks. Remission rates appear to be higher than seen in traditional medication studies. We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder. These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”
Michael Pollock, CEO at the Depression and Bipolar Support Alliance (DBSA), said: “Many people suffering with severe forms of depression find that existing treatments don’t work for them. We support any attempt to investigate alternative therapies. The approach of cycling through drugs that aren’t working is inadequate for anyone who is living with a mental health condition and disheartening for the family members and healthcare professionals who care for them. The results seen from this study are an early indicator of hope for those who are desperately in need of help.”
Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences, said: “This is an important and exciting moment for the mental health care community. It builds upon more than two decades of research into the viability of psychedelic compounds to treat mental health conditions and demonstrates the potential it has in helping people living with treatment-resistant depression. It’s encouraging to see how far this field has progressed in the last 20 years and I look forward to further research.”
In addition to this topline data, COMPASS is conducting comprehensive secondary analyses which are expected to further inform the clinical development programme for COMP360 psilocybin therapy. In the meantime, this promising topline data will be shared in an expeditious manner with regulators as part of an ongoing dialogue.
Notes to editors:
The COMPASS management team will host a conference call at 1:00pm UK (8.00am ET) on 9 November. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054.
The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.
About treatment-resistant depression (TRD)
More than 320 million people globally suffer with major depressive disorder (MDD)5, the leading cause of disability worldwide and one of the fastest growing mental health illnesses6. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)7. 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 patients8.
About the COMP360 psilocybin therapy phase IIb study
The phase IIb study was a dose-finding study, assessing the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression assessments were made by an independent, blinded rater. The primary endpoint is the change in the MADRS total score from baseline to week 3.
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. We are 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.
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.
*Notes: MADRS = Montgomery-Åsberg Depression Rating Scale response = ≥50% decrease in MADRS total score from baseline remission = MADRS total score ≤10 protocol-defined sustained response = patients meeting the MADRS response criteria from week 3 until week 12 sustained response = patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of week 6 and week 9
1 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
2 Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012 6: 369–388
3 Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018235:362-367
4 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. 202029:e63
5 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]
6 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]
7 Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012 6: 369–388.
8 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.
- Mock patient in trial site therapy room
- Trial site therapy room