Compass Pathways plc CMPS released data from the Phase 3 COMP005 trial, the first of two Phase 3 trials evaluating COMP360 for treatment-resistant depression (TRD).
Despite meeting the primary endpoint, the company’s stock experienced a significant decline. This was largely attributed to investor and analyst expectations for a more pronounced clinical effect.
The ongoing COMP005 trial is a randomized, double-blind, placebo-controlled study, which has dosed 258 participants and aims to assess the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD.
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The trial comprises three parts: Part A, which has recently concluded and was blinded through 6 weeks; Part B, which remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.
The trial met its primary endpoint, the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the active treatment group and the placebo group at week 6.
A single dose of COMP360 25 mg versus placebo demonstrated a statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.6 in change at the primary endpoint.
The company plans to discuss these preliminary COMP005 data with the U.S. Food and Drug Administration (FDA), which has not yet reviewed the data.
The second ongoing pivotal Phase 3 COMP006 trial continues to enroll well, with 26-week data expected in the second half of 2026.
Key COMP005 Findings
Efficacy Data (MADRS): Single dose of COMP360 25 mg versus placebo with a mean treatment difference of -3.6 points.
Reuters noted that while Compass said the results were “statistically significant,” some analysts and investors were disappointed, as they had hoped for a five-point drop in symptoms, sending the stock down almost 47%.
Based on the latest data review for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360, and there are no new or unexpected safety findings. Neither study has evidence of a clinically meaningful imbalance between treatment arms in suicidality.
Price Action: CMPS stock is trading lower by 47.3% to $2.44 at last check on Monday.
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