Neumora Therapeutics saw a drop of more than 80% in its share price following the announcement of a Phase III failure in major depressive disorder (MDD).
The Massachusetts-headquartered company鈥檚 Phase III KOASTAL-1 study (NCT06029426) was investigating its lead candidate navacaprant, a kappa type opioid receptor antagonist that acts by modulating the dopamine and reward processing pathways, for the treatment of MDD. The drug failed to demonstrate statistically significant improvements in the primary endpoint of change from baseline in the Montgomery-脜sberg depression rating scale (MADRS) total score at Week 6. Navacaprant also did not cause statistically significant improvements along the Snaith-Hamilton pleasure scale (SHAPS), as per a 2 January press release.
Prior to the release of these results, global sales for navacaprant were expected to reach $922m in 2030, as per GlobalData, the parent company of 污污漫畫 Technology.
The KOASTAL-1 trial is the first of three replicate clinical studies in the KOASTAL program for navacaprant. The clinical program also includes the open-label extension study, KOASTAL-LT, investigating the long-term safety and efficacy of navacaprant. The KOASTAL-2 (NCT06058013), KOASTAL-3 (NCT06058039), and KOASTAL-LT (NCT06058039) trials are ongoing, with plans for study completions by May 2025, June 2025, and September 2026, respectively, as per ClinicalTrials.gov.
Neumora鈥檚 shares took a last year following a US Food and Drug Administration clinical hold on a Phase I trial of its candidate NMRA-266 following reported preclinical data linking the drug with convulsions in rabbits. Currently, the company鈥檚 market cap sits at $345.74m. Neumora is investigating a range of drugs for the treatment of neurodegenerative and neuro-psychiatric diseases including schizophrenia and agitation in Alzheimer鈥檚 disease.
Despite the recent negative readout, Henry Gosebruch, the company鈥檚 CEO was encouraged by certain trends in the data, saying that further analysis would be done. Of note, was data suggesting female enrollees in the study experienced larger improvements in some endpoints compared to their male counterparts. Rob Lenz, the company鈥檚 executive vice president, said: 鈥淲e are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD. There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants.鈥�
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By GlobalDataThe differential efficacy of MDD drugs in females and males has been noted by other companies in this space, influencing their business strategies.
Gosebruch said the company鈥檚 cash balance of $342m as of the end of Q3 provides adequate runway into mid-2026. The company will provide additional updates on its overall pipeline at the upcoming J.P. Morgan Healthcare Conference, which will be held 13鈥�16 January.
