COMPASS Pathways completes COMP360 psilocybin therapy administration for 216 patients in large-scale phase IIb psilocybin therapy trial for treatment-resistant depression

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it has completed psilocybin administration to the target 216 patients in its phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression. This is the world’s largest psilocybin therapy trial to date.

The trial is a randomised controlled, double-blinded, dose-ranging study, investigating the safety and efficacy of psilocybin therapy and comparing a 25mg and 10mg dose of COMP360 psilocybin with a 1mg dose, administered in conjunction with psychological support from specially trained therapists. The 216th patient in the trial had their psilocybin session late last week. Although the target of 216 patients has been achieved and enrolment has now been closed, all enrolled patients who are in the run-in period and have not yet had their psilocybin therapy session, will remain in the trial. This means the number of patients included in the final analysis will be approximately 230, with all psilocybin sessions expected to be completed by 8 July.

Patients are followed-up for 12 weeks after their psilocybin session. COMPASS remains on track to report data in late 2021.  

Sue Stansfield PhD, Senior Vice-President, Clinical Operations, COMPASS Pathways, said, “Thank you to everyone on the team and to all our partners and trial sites who have kept this trial going over the last year, despite the pandemic. The safety of patients and of our teams has always been our first priority, and we have introduced measures such as air filtration units and therapists wearing clear masks, to ensure patients were as comfortable as possible in the midst of all the COVID precautions.”

Completing recruitment to our trial is a tremendous milestone and a huge step forward towards our goal of getting psilocybin therapy to patients in need. We are fortunate to be doing this in collaboration with hundreds of talented and dedicated people from our 22 trial sites in 10 countries – including investigators, raters, study coordinators and nurses, therapists, and pharmacists – as well as our supply chain and clinical research partners. This has been an amazing effort by the whole team, who are delivering the world’s largest psilocybin therapy clinical trial, in the middle of a pandemic, and with all the uncertainties and changes brought on by national lockdowns and site closures.

George Goldsmith, CEO and Co-founder, COMPASS Pathways

“We’d like to recognise and thank everyone who helped to make this trial happen, including all the patients who participated. We are now looking forward to completing the trial, and analysing and sharing the data later in the year. COMPASS is well financed following our recent fundraising of over $165m. We expect to be ready to commence phase III trials as soon as we receive regulatory support to do so, based on our phase IIb results.”

To view the original press release in its entirety click here

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