Neumora’s Navacaprant Fails to Meet Expectations in First Phase 3 Trial for Major Depressive Disorder

Trial Failure:
Neumora Therapeutics' experimental drug navacaprant failed to demonstrate a statistically significant improvement in reducing depressive symptoms compared to a placebo in the first of three Phase 3 trials (KOASTAL-1 Study) for major depressive disorder (MDD)13.

Efficacy Signal in Female Participants:
Despite the overall failure, navacaprant showed an efficacy signal in female participants, which the company plans to further analyze3.

Safety Profile:
Navacaprant was generally well-tolerated with a safety profile comparable to placebo, and no serious adverse events were reported3.

Future Plans:
Neumora expects to share additional updates on the navacaprant development program at the J.P. Morgan Healthcare Conference on January 14, 20253.

Financial Impact:
The failure of the first Phase 3 trial led to a significant drop in Neumora's stock value, plummeting by more than 80%45.

KOASTAL Program:
The KOASTAL program includes three replicate Phase 3 studies (KOASTAL-1, KOASTAL-2, and KOASTAL-3) designed to evaluate the efficacy and safety of navacaprant monotherapy in adult patients with moderate-to-severe MDD3.

Sources:

1. https://endpts.com/neumoras-major-depression-drug-flunks-first-of-three-phase-3-trials/

3. https://ir.neumoratx.com/news-releases/news-release-details/neumora-therapeutics-reports-data-koastal-1-study-navacaprant

4. https://www.fiercebiotech.com/biotech/neumora-stumbles-start-phase-3-depression-readout-run-sending-stock-down-80

5. https://www.biopharmadive.com/news/neumora-depression-drug-data-results-stock-navacaprant/736263/