- COMPASS Pathways has completed their flagship COMP360 psilocybin therapy administration for 216 patients.
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.
“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. 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.”George Goldsmith, CEO and Co-founder, COMPASS Pathways
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 are currently conducting 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, US. Our vision is a world of mental wellbeing. www.compasspathways.com