COMP360 psilocybin therapy in TRD

The New England Journal of Medicine publishes results from phase 2b trial of

COMP360 psilocybin therapy for treatment-resistant depression

Press release Posters NEJM publication

About the phase 2b trial

Our randomised controlled phase 2b study of psilocybin therapy in treatment-resistant depression is the largest psilocybin therapy clinical trial ever conducted, with 233 patients across 22 sites in 10 countries across Europe and North America. This trial assessed the safety and efficacy of COMP360 psilocybin therapy in three doses: 1mg, 10mg, 25mg. The results, published in the New England Journal of Medicine, show that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks.

"25% of patients had a sustained response"

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways

"Seeing a number of people improve during the course of their participation has been just terrific"

Scott Aaronson, MD, chief science officer, Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt

"This study is one of the most interesting that's come along really this century"

Professor Allan Young, Director of the Centre for Affective Disorders at King’s College London, and Principal Investigator on the trial’s site at King’s College London – Institute of Psychiatry, Psychology & Neuroscience*

"It's really exciting to see that this kind of finding was the result of a rigorous study..."

Professor David Hellerstein, Professor of Clinical Psychiatry and Principal Investigator on the trial’s site at Columbia University, New York**

"The psychological support model is a really important aspect of the therapy..."

Dr Stephanie Knatz Peck, clinical psychologist and a therapist on the trial

About the NEJM publication and what’s next

Our phase 2b study, which has been published in the New England Journal of Medicine, has informed our clinical development programme for COMP360 psilocybin therapy. We are planning to start our phase 3 programme in 2022. This will enable us to move closer to making COMP360 psilocybin therapy, if approved, accessible to patients in need.

“We've been delighted to be accepted for publication in the New England Journal of Medicine”

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways

“The New England Journal of Medicine is very well regarded, has huge impact, and that’s what this field needs”

George Goldsmith, Executive Chairman and Co-founder, COMPASS Pathways

"We are looking to start the phase 3 programme before the end of the year"

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways

Learn more

Our phase 2b clinical trial in numbers

Timeline on research into psilocybin

About psilocybin therapy

We conducted an exploratory study of COMP360 psilocybin therapy in combination with antidepressants.

Read about the results

 

*Professor Allan Young was the Principal Investigator on COMPASS Pathways’ phase 2b trial site at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London and Coordinating Principal Investigator for the UK

**Professor David Hellerstein was the Principal Investigator on COMPASS Pathways’ phase 2b trial site at Columbia University, New York