Neumora Therapeutics, Inc. (NASDAQ: NMRA) revealed encouraging findings from its Phase 1b clinical evaluation of NMRA-511, a drug candidate designed to address agitation symptoms in patients suffering from Alzheimer's disease (AD). The announcement on Monday highlighted that NMRA-511 produced a clinically meaningful impact on agitation, further supported by a favorable safety and tolerability profile.
The Phase 1b investigation comprised two parts: Part A involved healthy elderly adults, while Part B focused explicitly on individuals exhibiting agitation tied to dementia resulting from AD. These comprehensive assessments aimed to gauge both the drug’s safety and its effect on agitation behaviors.
Results from Part B proved particularly noteworthy. Patients administered NMRA-511 demonstrated improvements on the Cohen-Mansfield Agitation Inventory (CMAI), a widely validated clinical scale that measures the frequency of 29 different agitated behaviors. Specifically, the treatment group exhibited placebo-adjusted decreases in CMAI total scores of 2.6 points at six weeks and 2.1 points at eight weeks after initiating treatment.
Additionally, within the subset of patients characterized by elevated anxiety, NMRA-511’s effect was even more pronounced. In this population, the placebo-adjusted reductions from baseline CMAI scores reached 7.6 points at week six and 5.6 points at week eight, suggesting a robust response among those with higher anxiety levels.
Regarding safety, NMRA-511 was well tolerated throughout the study. Treatment-emergent adverse events (TEAEs) were generally mild to moderate, and critically, the trial reported no incidents of somnolence or sedation, potential side effects often concerning in CNS-active medications. Discontinuations attributed to TEAEs were low, totaling just 2.5%.
Building on these foundational results, Neumora Therapeutics is preparing to advance NMRA-511 through subsequent stages of development. The company plans to initiate a multiple ascending dose extension study at higher doses in 2026, allowing for evaluation of the drug’s safety and efficacy at escalated levels. Furthermore, Neumora intends to develop an extended-release formulation to enable convenient once-daily dosing, also targeted for 2026. The progression will culminate in the launch of a Phase 2/3 dose-ranging clinical trial to further characterize the drug’s therapeutic profile.
Alongside NMRA-511 developments, Neumora announced an expansion in patient enrollment across its KOASTAL clinical trials testing navacaprant, a compound for major depressive disorder. Enrollment targets in these studies will increase by up to 25% beyond the original objective of 332 participants. The company anticipates sharing joint topline results for the KOASTAL-2 and KOASTAL-3 studies in the second quarter of 2026.
The market responded to these updates, as Neumora Therapeutics saw its shares rise by 2.11% to $1.69 during Monday’s trading session, reflecting investor interest in the company’s clinical advancements.