Compass Pathways plc (NASDAQ: CMPS) released 52-week topline results from Part C of its Phase 3 COMP005 trial evaluating COMP360, a synthetic psilocybin formulation, for treatment-resistant depression (TRD).

The open-label portion of the trial, which ran from Week 26 to Week 52, enrolled approximately 70% of the original 258 U.S. participants. Among those in the original 25 mg arm, about 80% (n=90) received an additional dose in Part C, resulting in an average 13-point reduction in MADRS score from baseline at Week 52. Participants in the placebo arm who received their first dose of COMP360 25 mg in Part C showed a mean 10-point reduction in MADRS score from baseline by the end of Part C.

Across all Part C participants who received a 25 mg dose, the company reported response rates of 40% to 45% and remission rates of approximately 30% between Day 1 and Week 6 following treatment. The company stated the safety profile in Part C was consistent with earlier trial phases, with no new safety signals observed.

The COMP005 trial was a randomized, double-blind, placebo-controlled study with participants randomized 2:1 to receive a single 25 mg dose of COMP360 or placebo in Part A.

Chief Executive Officer Kabir Nath said the company's rolling NDA submission is underway, with a final submission expected in the fourth quarter and a potential launch in the first half of next year, subject to FDA approval.