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 Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) scale.
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MADRAS is a measure of depressive severity and SHAPS is a clinical assessment tool used to measure anhedonia, which is the inability to experience pleasure from activities usually found enjoyable.
Navacaprant and placebo led to a -12.5 change from baseline on the primary endpoint.
Navacaprant showed a decline of 5.8 points on the secondary endpoint versus a decline of 5.5 on the placebo.
“We are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD. There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants,” said Rob Lenz, executive vice president, head of research and development, Neumora.
The company highlights its cash balance of $342 million as of the end of the third quarter, providing a runway into mid-2026. It looks forward to providing additional updates on the Navacaprant development program and pipeline at the J.P. Morgan Healthcare Conference.
Navacaprant was shown to be safe and generally well-tolerated, and no serious adverse events were reported. 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.
Price Action: At last check Thursday, NMRA stock was down 83.6% to $1.74 during the premarket session.
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