COMPASS Pathways announces publication of phase 2b study of

After a single 25mg dose of COMP360 psilocybin remedy, roughly 30% of sufferers with

treatment-resistant despair (TRD) have been in remission at week 3

Sustained response seen by way of week 12 in twice the quantity of TRD sufferers that obtained 25mg dose vs 1mg

Phase 3 pivotal programme anticipated to start in 2022

LONDON, Nov. 03, 2022 (GLOBE NEWSWIRE) — COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a psychological well being care firm devoted to accelerating affected person entry to evidence-based innovation in psychological well being, as we speak introduced that The New England Journal of Medicine (NEJM), the world’s main peer-reviewed medical journal, has printed the optimistic outcomes from its phase 2b trial of COMP360 psilocybin remedy for treatment-resistant despair (TRD) – the biggest study of its sort.

The goal of the randomised, managed, double-blind phase 2b study was to know the efficacy and security of a single dose of investigational COMP360 psilocybin (25mg or 10mg), in comparison with 1mg, in sufferers with TRD. After a single 25mg dose of COMP360 psilocybin, together with psychological assist, 29.1% of individuals with TRD have been in remission by week 3 (p<0.002) – that is larger than the response charges seen for equal strains of remedy within the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study*, a big potential medical trial of main depressive dysfunction carried out to find out the effectiveness of totally different remedies for despair.

“The publication of our COMP360 psilocybin therapy study in the most prestigious peer-reviewed medical journal in the world is a proud moment for everyone involved,” mentioned Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways. “We saw positive results in a particularly difficult to treat group of patients, and the highest dose of COMP360 psilocybin had the greatest impact on people’s depression. This suggests that COMP360 psilocybin has a true pharmacological effect, a finding that is critical for it to be recognised as a new treatment option in the future. We look forward to starting our phase 3 programme later this year, moving us closer to providing COMP360 psilocybin with psychological support for patients who desperately need it.”

Further element: phase 2b study synopsis

In the phase 2b trial, 233 sufferers with TRD obtained both 1mg, 10mg or 25mg COMP360 psilocybin, together with psychological assist from specifically skilled therapists.

• Rapid discount in signs: Approximately 30% of sufferers within the 25mg group have been in remission at week 3 (29.1%). This is larger than the response charges seen for equal strains of remedy within the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, a big potential medical trial of main depressive dysfunction carried out to find out the effectiveness of totally different remedies for despair
  • Patients who obtained a single 25mg dose of COMP360 psilocybin, together with psychological assist, skilled a extremely statistically important, fast discount in signs of despair after three weeks: the distinction between the 25mg group and 1mg group was -6.6 on the MADRS** despair scale at week 3, p<0.001
• Sustained response: Double the quantity of sufferers who obtained a 25mg dose had a sustained response at week 12, in comparison with those that obtained 1mg (20.3% of sufferers within the 25mg group vs 10.1% within the 1mg group)
• Well-tolerated: COMP360 psilocybin was usually well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness have been the commonest adversarial occasions the place a dose-related enhance in incidence was evident
• Safety monitoring: Suicidal ideation and intentional self-injury have been seen in all remedy teams, as is widespread in TRD research. Most circumstances occurred greater than every week after the COMP360 psilocybin session. There was no imply worsening of suicidal ideation scores on the MADRS scale in any remedy group. Suicidal behaviours have been reported not less than one month after COMP360 administration for 3 non-responders within the 25mg arm

Scott Aaronson, MD, Chief Science Officer of the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt Health System, and a Principal Investigator on the trial, mentioned, “Over 100 million people around the world suffer with treatment-resistant depression, and haven’t found relief from existing therapies. With every new treatment, the chance of responding decreases significantly, and patients become even more hopeless. Yet in this study, a substantial number of patients in the 25mg group experienced improvement in their symptoms of depression, with the effects lasting for up to three months. I’m proud to have been part of this important study and to see the results recognised today by such a respected journal.”

Data from the phase 2b trial was introduced in November and December 2021, and offered on the American Psychiatric Association annual assembly in New Orleans in May 2022. COMPASS Pathways offered the design of its phase 3 medical programme on 12 October 2022 and plans to start by the top of the yr.

*Sinyor M, Schaffer A, Levitt A. The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Trial: A Review. The Canadian Journal of Psychiatry. 2010;55(3):126-135. doi:10.1177/070674371005500303
**MADRS = Montgomery-Åsberg Depression Rating Scale, a diagnostic questionnaire used to measure the severity of despair. The next rating signifies extra extreme despair.
Response = ≥50% lower in MADRS complete rating from baseline; remission = MADRS complete rating ≤10; sustained response = sufferers assembly the MADRS response standards from week 3 and in any respect subsequent visits till week 12.

About treatment-resistant despair (TRD)

More than 320 million individuals globally undergo with main depressive dysfunction (MDD)¹, the main trigger of incapacity worldwide and one of the quickest rising psychological well being diseases². About a 3rd of these sufferers – 100 million individuals – aren’t helped by current therapies and undergo with treatment-resistant despair (TRD)³. As many as 30% of these try suicide not less than as soon as throughout their lifetime^4,5. TRD carries two to 3 instances the medical prices of a non-TRD MDD affected person, and sufferers with TRD have the next all-cause mortality in contrast with non-TRD MDD sufferers⁶. The TRD inhabitants is by definition tougher to deal with and extra prone to relapse than sufferers with main depressive dysfunction. In 2018, COMPASS obtained FDA Breakthrough Therapy designation for its COMP360 psilocybin remedy for TRD.

About COMP360 psilocybin remedy

COMP360 is our proprietary stabilised, high-purity polymorphic crystalline synthesised formulation of psilocybin. Psilocybin acts on serotonin 2a receptors within the mind. It’s believed that appearing on this receptor could make the mind work with higher flexibility, permitting areas to attach and talk extra simply. Connections underlying unhealthy mind states, akin to TRD, could reconnect in a more healthy approach after the drug results have worn off⁷.

About the COMP360 psilocybin remedy phase 2b study

This randomised, managed, multicentre, double-blind phase 2b trial is the biggest psilocybin remedy medical trial ever carried out, with 233 sufferers from 10 nations in North America and Europe. 94% of the sufferers had no prior expertise with psilocybin. The goal of the trial was to seek out the suitable dose for a bigger, pivotal phase 3 programme, which COMPASS expects to start in 2022.

The trial assessed the protection and efficacy of COMP360 psilocybin remedy at three doses: 1mg, 10mg, 25mg. A complete of 233 sufferers enrolled within the study and have been randomised and blinded into three arms comprising 79 sufferers for every of the 25mg and 1mg doses, and 75 sufferers for the 10mg dose. Patients have been adopted up for 12 weeks. The trial used the Montgomery-Åsberg despair score scale (MADRS), a broadly used and accepted scale for assessing despair; assessments have been made by an unbiased, blinded rater. The major endpoint was the change within the MADRS complete rating from baseline to week 3.

COMP360 psilocybin was usually well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness have been the commonest adversarial occasions the place a dose-related enhance in incidence was evident. Suicidal ideation and intentional self-injury have been seen in all remedy teams (as is repeatedly noticed in a TRD inhabitants). The majority of circumstances occurred greater than every week after the COMP360 psilocybin session. There was no imply worsening of suicidal ideation scores on the MADRS scale in any remedy group. Suicidal behaviours have been reported not less than one month after COMP360 administration for 3 non-responders within the 25mg arm.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a psychological well being care firm devoted to accelerating affected person entry to evidence-based innovation in psychological well being. Our focus is on enhancing the lives of those that are struggling with psychological well being challenges and who should not helped by present remedies. We are pioneering the event of a brand new mannequin of psilocybin remedy, during which our proprietary formulation of artificial psilocybin, COMP360, is run together with psychological assist. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA) and has obtained Innovative Licensing and Access Pathway (ILAP) designation within the UK for treatment-resistant despair (TRD). We have accomplished a phase 2b medical trial of psilocybin remedy for TRD, in 22 websites throughout Europe and North America and we’re making ready to start a phase 3 programme by the top of 2022. This was the biggest randomised, managed, double-blind psilocybin remedy medical trial ever carried out, and our topline knowledge confirmed a statistically important (p<0.001) and clinically related enchancment in depressive symptom severity after three weeks for sufferers who obtained a single excessive dose of COMP360 psilocybin with psychological assist. We are additionally working phase 2 medical trials of COMP360 psilocybin remedy for post-traumatic stress dysfunction (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with workplaces in New York and San Francisco within the US. Our imaginative and prescient is a world of psychological wellbeing. www.compasspathways.com

Availability of different details about COMPASS Pathways

Investors and others ought to notice that we talk with our traders and the general public utilizing our web site (www.compasspathways.com), our investor relations web site (ir.compasspathways.com), and on social media (LinkedIn), together with however not restricted to investor shows and investor reality sheets, US Securities and Exchange Commission filings, press releases, public convention calls and webcasts. The info that we put up on these channels and web sites could possibly be deemed to be materials info. As a end result, we encourage traders, the media, and others excited by us to evaluate the data that’s posted on these channels, together with the investor relations web site, regularly. This record of channels could also be up to date now and again on our investor relations web site and will embrace extra social media channels. The contents of our web site or these channels, or some other web site which may be accessed from our web site or these channels, shall not be deemed included by reference in any submitting below the Securities Act of 1933.

Forward-looking statements

This press launch incorporates forward-looking statements throughout the that means of the Private Securities Litigation Reform Act of 1995, as amended. In some circumstances, forward-looking statements may be recognized by terminology akin to “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “believe”, “contemplate”, “estimate”, “potential”, “continue” and “ongoing,” or the destructive of these phrases or different comparable terminology, though not all forward-looking statements comprise these phrases. Forward-looking statements embrace specific or implied statements regarding, amongst different issues, the protection or efficacy of COMP360 psilocybin remedy as a remedy for despair, COMPASS’s expectations for the timing of its pivotal phase 3 programme and the potential for the pivotal phase III programme or different trials to assist regulatory filings and approvals, COMPASS’s business technique and targets, together with its potential to launch and commercialise COMP360 psilocybin remedy, COMPASS’s potential to proceed to advance its analysis or develop plans to carry COMP360 psilocybin remedy to sufferers, together with COMP360, and COMPASS’s expectations concerning the advantages of its COMP360 psilocybin remedy. The forward-looking statements on this press launch are neither guarantees nor ensures, and you shouldn’t place undue reliance on these forward-looking statements as a result of they contain recognized and unknown dangers, uncertainties, and different elements, many of that are past COMPASS’s management and which may trigger precise outcomes, ranges of exercise, efficiency or achievements to vary materially from these expressed or implied by these forward-looking statements.

These dangers, uncertainties, and different elements embrace, amongst others: medical improvement is prolonged and unsure, and due to this fact our medical trials could also be delayed or terminated, or could by no means advance to a regulatory submitting or assist regulatory approval; and people dangers and uncertainties described below the heading “Risk Factors” in COMPASS’ most up-to-date annual report on Form 10-Ok or quarterly report on Form 10-Q and in different studies we have now filed with the U.S. Securities and Exchange Commission (“SEC”), which can be found on the SEC’s web site at www.sec.gov. Except as required by regulation, COMPASS disclaims any intention or accountability for updating or revising any forward-looking statements contained on this press launch within the occasion of new info, future developments or in any other case. These forward-looking statements are primarily based on COMPASS’s present expectations and communicate solely as of the date hereof.

Enquiries

Media: Amy Lawrence, [email protected], +44 7813 777 919
Investors: Stephen Schultz, [email protected], +1 401 290 7324

References:

[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 [Accessed 21 October 2021]
[2] 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]
[3] Al-Harbi KS. Treatment-resistant despair: therapeutic traits, challenges, and future instructions. Patient Preference and Adherence. 2012; 6: 369–388.
[4] Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant despair and suicidality. Journal of Affective Disorders. 2018;235:362-367
[5] Dong M, Lu L, Zhang L, et al. Prevalence of suicide makes an attempt in bipolar dysfunction: a scientific evaluate and meta-analysis of observational research. Epidemiology and Psychiatric Sciences. 2020;29:e63
[6] Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in sufferers with treatment-resistant despair: a cohort study within the US inhabitants. Annuals of General Psychiatry. 2019; 18:23.
[7] Carhart-Harris, R. L., & Friston, Ok. (2019). REBUS and the anarchic mind: towards a unified mannequin of the mind motion of psychedelics. Pharmacological critiques, 71(3), 316-344.

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