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Compass Pathways plc (NASDAQ:CMPS) announced Monday that its Phase 3 COMP005 trial for COMP360, a synthetic formulation of psilocybin, met its primary endpoint in patients with treatment-resistant depression. The company reported that a single 25 mg dose of COMP360 resulted in a statistically significant reduction in symptom severity compared to placebo at week 6, with a mean treatment difference of -3.6 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) and a p-value of less than 0.001.
Safety data reviewed by the Data Safety Monitoring Board chair, in a statement dated June 19, indicated that findings were consistent with previous studies and showed no new or unexpected safety issues. There was no evidence of a clinically meaningful imbalance in suicidality between treatment groups in either the COMP005 or the parallel COMP006 study.
The COMP005 trial is a randomized, double-blind, placebo-controlled study involving 258 participants with moderate-to-severe depression across 32 sites in the United States. The study is evaluating the efficacy and safety of a single 25 mg dose of COMP360 compared to placebo over several phases, with the first phase recently completed.
The company also provided an update on the ongoing COMP006 trial, which is enrolling up to 568 participants in North America and Europe. COMP006 is comparing two fixed doses of COMP360, taken three weeks apart, to lower doses in a similar multi-phase design.
Compass Pathways stated it plans to discuss the preliminary COMP005 data with the U.S. Food and Drug Administration, which has not yet reviewed the results. The company anticipates sharing 26-week data for COMP005 after all participants in COMP006 have completed the initial phase, with 26-week data from COMP006 expected in the second half of 2026.
This information is based on a press release statement included in a filing with the U.S. Securities and Exchange Commission.
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