Neumora initiates Phase 2 study of navacaprant in bipolar depression

Neumora Therapeutics announced the initiation of a Phase 2 study evaluating the safety and efficacy of navacaprant in people with bipolar depression. Navacaprant is an oral 80 mg once-daily best-in-class kappa opioid receptor antagonist, a novel mechanism of action in development for the treatment of major depressive disorder and bipolar depression. The randomized, double-blind, placebo-controlled, Phase 2 clinical trial is designed to evaluate the safety and efficacy of navacaprant in people with depression associated with bipolar II disorder. The study will evaluate navacaprant 80 mg monotherapy in approximately 60 patients with a moderate-to-severe major depressive episode. The primary endpoint of the study is change in MADRS at Week 6, and key secondary endpoints will evaluate the impact of navacaprant on anhedonia as well as other measures. Neumora expects to report topline data from this Phase 2 study in the second half of 2025. Results from this proof-of-concept study will inform further development of navacaprant in bipolar disorder, potentially including development in broader bipolar disorder populations.