Neumora Therapeutics Reports Disappointing Results from KOASTAL-1 Study

Neumora Therapeutics, Inc. (NASDAQ: NMRA) recently disclosed the outcome of its Phase 3 KOASTAL-1 study for navacaprant in the treatment of major depressive disorder (MDD). The company revealed that the study did not display a statistically significant enhancement in the primary endpoint of lowering depressive symptoms compared to the placebo.

In a press release issued on January 2, 2025, Neumora Therapeutics outlined that while navacaprant exhibited an efficacy signal among female participants, it failed to meet endpoints related to the reduction of depressive symptoms as measured by MADRS total score and the Snaith-Hamilton Pleasure Scale.

Rob Lenz, the executive vice president overseeing research and development at Neumora, expressed disappointment in the study results, emphasizing the need to explore the disparity in responses between male and female participants.

Despite the setback, Henry Gosebruch, the company’s president and CEO, remained committed to their mission of aiding individuals coping with brain diseases. He highlighted that the company’s robust financial position, with a cash balance of $342 million as of the third quarter’s conclusion, provides support until mid-2026. Neumora plans to present additional updates regarding the navacaprant development program at the upcoming J.P. Morgan Healthcare Conference.

The KOASTAL-1 study enrolled 383 adult patients with MDD and indicated that navacaprant was generally well-tolerated with no serious adverse events noted. The company plans to continue its Phase 3 studies, including KOASTAL-2, KOASTAL-3, and KOASTAL-LT, to further assess the safety and efficacy of navacaprant in MDD treatment.

Navacaprant, a selective kappa opioid receptor (KOR) antagonist, is designed to modulate dopamine and reward processing pathways. This mechanism targets mood regulation, cognition, reward, and behavior, offering a new approach to treating MDD and other neuropsychiatric disorders.

MDD, a pervasive mental health condition affecting millions of Americans, especially women, presents symptoms like low mood, loss of interest, and several functional impairments. Neumora is dedicated to developing innovative therapies for brain diseases, with a focus on precision medicine for improved treatment outcomes and patient well-being.

Investors are eagerly anticipating further developments from Neumora Therapeutics as they navigate the challenges posed by the KOASTAL-1 study outcomes.

This press release contains forward-looking statements, and investors are advised to consider the risks and uncertainties related to clinical drug development and regulatory approvals when interpreting these statements.

For further details on Neumora’s ongoing initiatives, interested parties can refer to the Company’s filings with the Securities and Exchange Commission.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Neumora Therapeutics’s 8K filing here.

About Neumora Therapeutics

Neumora Therapeutics, Inc, a clinical-stage biopharmaceutical company, engages in developing therapeutic treatments for brain diseases, neuropsychiatric disorders, and neurodegenerative diseases. The company develops navacaprant (NMRA-140), a novel once-daily oral kappa opioid receptor antagonist, which is in phase 3 clinical trials for the treatment of major depressive disorder.