Compass Pathways plc (NASDAQ:CMPS) reported 52-week topline results from Part C of its Phase 3 COMP005 trial evaluating COMP360, its synthetic psilocybin formulation, in treatment-resistant depression.
The open-label portion of the study covered Week 26 through Week 52 and included approximately 70% of the original 258 U.S. participants.
Among participants originally assigned to the 25 mg COMP360 group, approximately 80%, or 90 participants, received an additional dose during Part C. At Week 52, this group recorded an average 13-point reduction from baseline on the Montgomery-Åsberg Depression Rating Scale, or MADRS.
Participants originally assigned to placebo who received their first 25 mg dose of COMP360 during Part C recorded a mean 10-point reduction in MADRS score from baseline by the end of the period.
Response rates reported at 40% to 45%
Across all Part C participants receiving a 25 mg dose, Compass reported response rates ranging from 40% to 45% between Day 1 and Week 6 following treatment.
Remission rates were approximately 30% over the same post-treatment period.
The company said the safety profile observed during Part C was consistent with earlier phases of the trial and that no new safety signals were identified.
COMP005 was designed as a randomised, double-blind, placebo-controlled study. In Part A, participants were randomised on a 2:1 basis to receive either a single 25 mg dose of COMP360 or placebo.
Compass expects final NDA submission in fourth quarter
Chief Executive Officer Kabir Nath said Compass has begun its rolling New Drug Application submission process.
The company expects to complete the submission in the fourth quarter, with a potential launch in the first half of next year, subject to approval from the U.S. Food and Drug Administration.
Compass Pathways stock price
