US clinical-stage biopharmaceutical company Neumora Therapeutics Inc (Nasdaq: NMRA) on Thursday announced results from the Phase 3 KOASTAL-1 Study of navacaprant for the treatment of major depressive disorder (MDD).

The first of three replicate Phase 3 studies that comprise the pivotal KOASTAL programme, KOASTAL-1 did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Asberg 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.

Rob Lenz, executive vice president, head of research and development at Neumora, said: "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."

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