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