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Neumora’s KOSTAL-1 Study of Navacaprant Yields Disappointing Results

The study failed to demonstrate a statistically significant improvement in depression symptoms compared to placebo.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Neumora Therapeutics Inc. a clinical-stage biopharmaceutical company, has announced results from the Phase 3 KOASTAL-1 Study of navacaprant for the treatment of major depressive disorder (MDD).

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.

“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.

“We will not waver on our mission to make a difference for people living with brain diseases, which our broad pipeline of novel programs has the potential to address. The outcome of KOASTAL-1 is not what we expected, but there are encouraging trends in the data that we are analyzing,” added Henry Gosebruch, president and CEO, Neumora.

The KOASTAL-1 study enrolled 383 adult patients with MDD. Navacaprant was shown to be safe and generally well-tolerated with no serious adverse events reported. There was no signal for increased suicidal ideation or suicidal behavior compared to placebo.

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