Compass Pathways announced today that its investigational psilocybin treatment, COMP360, has demonstrated rapid and clinically meaningful improvements in patients with treatment-resistant depression in two Phase 3 trials. The company indicated it will now engage with the Food and Drug Administration (FDA) regarding potential submission for approval, potentially paving the way for the first psilocybin-based medicine to reach the market.
The Phase 3 trials showed significant improvement over placebo, with durable results lasting up to 26 weeks, according to a statement released by Compass Pathways. The findings build on earlier positive results from a Phase 2b trial, published in the New England Journal of Medicine, which assessed the safety and efficacy of COMP360 psilocybin in 233 patients across 22 sites in Europe and North America. That earlier study indicated a single 25mg dose, combined with psychological support, was associated with a statistically significant reduction in depressive symptoms after three weeks (p<0.001), with responses sustained for up to 12 weeks.
“Seeing a number of people improve during the course of their participation has been just terrific,” said Scott Aaronson, MD, chief science officer at the Institute for Advanced Diagnostics and Therapeutics, Sheppard Pratt, in a video statement accompanying the Phase 2b trial results. 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, described the study as “one of the most interesting that’s come along really this century.”
The Phase 3 trial achieved its primary endpoint, demonstrating the rapid reduction of treatment-resistant depression symptoms. According to Compass Pathways, the treatment also exhibited a favorable safety profile. The company’s Chief Medical Officer, Dr. Guy Goodwin, noted that 25% of patients experienced a sustained response to the treatment, according to a poster presentation related to the Phase 2b trial.
The treatment involves a single dose of COMP360 psilocybin administered in conjunction with psychological support. Professor David Hellerstein, Professor of Clinical Psychiatry and Principal Investigator on the trial’s site at Columbia University, New York, emphasized the importance of the psychological support component, stating, “It’s really exciting to see that this kind of finding was the result of a rigorous study…”
STAT News reported today that the positive data could be sufficient for FDA approval of the treatment. Compass Pathways has not yet announced a specific timeline for submitting a New Drug Application to the FDA.
