Neumora Therapeutics Announces Initiation of Phase 2 Study of Navacaprant in Bipolar Depression

Potential to alleviate unmet need associated with depressed mood and anhedonia in bipolar depression; navacaprant has demonstrated the ability to improve these symptoms in MDD in a Phase 2 study

Navacaprant is also currently in Phase 3 development for the treatment of MDD with data from KOASTAL-1 anticipated in the fourth quarter of 2024

WATERTOWN, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today 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 (KOR) antagonist, a novel mechanism of action in development for the treatment of major depressive disorder (MDD) and bipolar depression.

“Navacaprant’s novel mechanism of action has the potential for broad benefit across multiple neuropsychiatric disorders, and there is a strong rationale to evaluate its efficacy in bipolar depression. A growing body of research has characterized the pathophysiologic underpinnings of anhedonia in bipolar depression, a key feature that often remains unaddressed by standard of care. Given that in Phase 2 navacaprant demonstrated the ability to meaningfully improve depressed mood and anhedonia in other populations, we believe it may also be effective in treating these symptoms in bipolar depression,” said Robert Lenz, M.D. Ph.D., executive vice president and head of research and development, Neumora. “This is important because people with bipolar depression experience significant unmet need due to the atypical symptomology and resistance to current treatment options they often experience.”

“It’s clear that there’s an urgent unmet need for new approaches in the treatment of bipolar depression. With the current treatment paradigm, patients often cycle through multiple lines of therapy that do not sufficiently treat depressive symptoms, resulting in significant negative impact on patients’ quality of life and ability to function,” said Dan Iosifescu, M.D., Professor, Department of Psychiatry at NYU Grossman School of Medicine. “With this unmet need in mind, it is encouraging to see new mechanisms in development to address depressive symptoms in bipolar disorder that are supported by biological rationale. In fact, research suggests that KOR antagonism can play an important role in improving depressed mood and anhedonia – a hypothesis that has been reinforced by positive results from multiple clinical studies.”