Compass Pathways’ psilocybin treatment demonstrated rapid and sustained effectiveness in patients with treatment-resistant depression during a second late-stage trial, according to a July 7 release. The results strengthen the company’s ongoing pursuit of approval from the U.S. Food and Drug Administration for its investigational therapy, COMP360.
The latest data from the Phase 3 COMP006 trial showed that 39% of patients with treatment-resistant depression who received two fixed doses of COMP360 experienced a clinically meaningful reduction in depression severity by week six. Those who responded maintained this improvement through week 26. Patients entering the study had depressive episodes lasting more than three years on average.
Of those achieving an initial response at week six, Compass reported that 30% later went into remission. A quarter of patients receiving only one dose achieved a clinically meaningful response, leading Compass to confirm the benefit of adding a second dose for some individuals. The new readout provides long-term insights following earlier six-week data released in February.
Safety outcomes were consistent with previous studies, with most adverse events being temporary and occurring on dosing days. The report disclosed one suicide among participants who had received Compass’ treatment; investigators determined it was unrelated to the therapy, as it occurred 80 days after dosing. Stifel noted there were at least three suicides during clinical testing for Johnson & Johnson’s ketamine-based Spravato program.
“The data collected to date supports the potential for COMP360 to usher in ‘a profound shift in mental health care,’” said Kabir Nath, CEO of Compass Pathways, adding that “COMP360 could allow patients to receive just a few doses per year, rather than staying on chronic, daily treatment.”
Compass plans to complete its rolling submission by the fourth quarter and anticipates launching COMP360 in early 2027 if approved. Analysts have expressed confidence about FDA approval prospects and projected peak sales reaching $1.5 billion for COMP360 if successful.
