Neumora Therapeutics Inc. (NASDAQ: NMRA) nosedived by more than 80 percent during pre-market trading following disappointing results from the Phase 3 trial of navacaprant, a drug being developed to treat major depressive disorders.
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According to the company, the study failed to show a statistically significant improvement in depressive symptoms compared to placebo as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). The asset was tested on 383 adult patients.
However, Neumora (NASDAQ: NMRA) said it observed efficacy signals in female participants, with a notable difference in their response to the drug as compared with its male enrollees.
Neumora (NASDAQ: NMRA) said it plans to further analyze such findings.
Navacaprant was shown to be generally well-tolerated with a safety profile comparable to placebo. During the trial, the company said participants did not report any adverse effects except for headache and diarrhea. It added that rates of treatment discontinuation due to adverse events were low.
Significant Portion of Participants Re-enroll to Extension Study
Despite the disappointing outcome, a significant portion of patients who completed six weeks of navacaprant treatment chose to enroll in the KOASTAL-LT extension study. The company is expected to provide additional updates on the development program at the upcoming JP Morgan Healthcare Conference.
Navacaprant is a novel kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for major depressive disorders. It is designed to modulate dopamine and reward processing pathways, which are important for mood regulation.
In the US, as many as 21 million adults suffer from depression, with women being nearly twice as likely to experience depression. Current treatments often fail to achieve remission and can have negative side effects.
Neumora Therapeutics has a therapeutic pipeline of seven clinical and preclinical neuroscience programs targeting a range of brain diseases. It is on a mission to redefine neuroscience drug development by advancing novel therapies for improved treatment outcomes.
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