Neumora Therapeutics (NMRA) announced results from the Phase 3 KOASTAL-1 Study of navacaprant for the treatment of major depressive disorder. The KOASTAL-1 Study is the first of three replicate Phase 3 studies that comprise the pivotal KOASTAL program. The study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the MADRS total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale scale. Navacaprant showed an efficacy signal in female participants; the company plans to further analyze results. Navacaprant was generally well-tolerated, with its safety profile comparable to placebo. There was no signal for increased suicidal ideation or suicidal behavior compared to placebo. The Phase 3 KOASTAL-2, KOASTAL-3 and KOASTAL-LT studies are ongoing.
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