New Hope for TRD
Compass Pathways' COMP360 Phase 3 Data Reinforce Durable Benefits for TRD, FDA Submission Underway
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Key Points
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A suicide incident occurred during COMP006 Part B but was determined to be unrelated to COMP360.
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Approximately 30% of week 6 responders in the 25 mg arm achieved remission after retreatment in Part B, indicating additional dosing can add benefit for some patients.
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The COMP006 trial used three fixed doses (25 mg, 10 mg, 1 mg) given three weeks apart, across nearly 600 dosed participants in North America and Europe.
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Participants in COMP006 comprised a highly chronic TRD population, with current depressive episodes lasting on average more than three years and more than six lifetime depressive episodes.
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A rolling NDA submission with the FDA is underway, with final submission targeted for Q4 2026 and potential launch in the first half of 2027, subject to regulatory clearance and potential DEA rescheduling.
Compass Pathways has released six-month results from its second Phase 3 trial of COMP360, a synthetic psilocybin treatment for treatment-resistant depression (TRD). The data show rapid and durable benefits, with 39% of patients in the 25 mg group achieving a clinically meaningful reduction in depression symptoms by week 6, according to PharmaTimes.
The company is now in a rolling FDA submission process, with a final NDA filing targeted for Q4 2026 and a potential U.S. launch in the first half of 2027, GuruFocus reported. The results build on earlier Phase 3 findings and strengthen Compass Pathways' path toward becoming the first approved psilocybin therapy in the United States.
Second Dose Adds Real Benefit for Many Patients
The COMP006 Part B trial gave patients up to two doses of COMP360, spaced three weeks apart. Patients received one of three fixed doses — 25 mg, 10 mg, or 1 mg. Nearly 600 participants took part across North America and Europe, according to GuruFocus.
Among week 6 responders in the 25 mg group, roughly 30% reached full remission after a second dose. That means the retreatment added benefit for patients who had already improved once. PharmaTimes noted these results confirm COMP360's profile as rapid-acting and long-lasting in a very hard-to-treat population.
A Severely Ill Patient Group With Years of Depression
The patients enrolled in COMP006 were not mildly depressed. Their current depressive episodes lasted more than three years on average. They had experienced more than six depressive episodes in their lifetimes, according to GuruFocus. This is what clinicians call a highly chronic TRD population.
Showing durable results in this group is significant. Most existing antidepressants fail these patients entirely. That COMP360 produced meaningful improvement — and held it through 26 weeks — makes the data stand out, PharmaTimes reported.
Safety Profile Held Steady With No New Red Flags
Side effects were mostly short-lived and tied to the dosing day itself. No new safety concerns emerged across the nearly 600-person trial. A suicide incident did occur during the study, but investigators determined it was unrelated to COMP360, according to Seeking Alpha.
The consistent safety data across both Phase 3 trials — COMP005 and COMP006 — strengthens the overall clinical package heading into the FDA review. Compass said the results are in line with what they saw in earlier studies.
Wall Street Sees NDA Submission as a Key Milestone
Stifel maintained its Buy rating on Compass Pathways after the six-month data dropped. The firm said the results support the benefit of a second dose and strengthen the company's case for FDA approval, according to Business Insider.
Compass is targeting a final NDA submission in Q4 2026. A launch could follow in the first half of 2027, pending FDA clearance and a potential DEA rescheduling of psilocybin. That regulatory step is required before any prescription product can reach patients, GuruFocus noted.
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