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Shares of Neumora Therapeutics NMRA lost more than 80% on Thursday after reporting the failure of its lead pipeline drug, navacaprant, in a late-stage study for major depressive disorder (MDD).
The phase III KOASTAL-1 study evaluated the efficacy and safety of navacaprant against placebo in adults with moderate-to-severe MDD over a six-week treatment period. The study failed to achieve its primary endpoint – treatment with the drug failed to demonstrate a significant improvement over placebo in alleviating depression symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
The study also failed to show statistically significant improvement in the reduction of anhedonia (the inability to feel pleasure), as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS).
The KOASTAL-1 study is one of the three late-stage studies in the KOASTAL program evaluating navacaprant in the MDD indication. Despite the study's failure, Neumora intends to continue the other two studies. In the meantime, management continues to further analyze the study results, as management claimed that the drug showed an efficacy signal in female patients.
NMRA Stock Performance
Following the news, shares of Neumora hit an all-time low of $1.83. The latest announcement failed to impress investors, who had high hopes for navacaprant based on data from a previously conducted mid-stage study.
In the past year, Neumora Therapeutics’ shares have plummeted 87.5% compared with the industry’s 13.6% decline.
Image Source: Zacks Investment Research
More on NMRA’s KOASTAL-1 Study Results
A total of 383 study participants were enrolled in the KOASTAL-1 study, who were randomized into two equal groups – one receiving navacaprant and the other receiving placebo.
Data from the study revealed that patients in both groups achieved the same scores on the MADRS scale, which was an average 12.5-point decrease in depression symptoms. MADRS is a metric showing the improvement of depressive symptoms in MDD patients compared with placebo after the treatment period. A higher MADRS score reflects greater depression severity.
However, Neumora's reported results revealed a variation in response based on gender. Men who received navacaprant achieved an average 10.6-point decrease in depression symptoms, compared to an average 14-point decrease in women. When comparing these results against their respective placebo groups, the results favored the male patients – men who took the placebo experienced an average 13.8-point decrease compared to the average 11.4-point decrease observed in women.