Neumora Therapeutics Announces Positive Results from NMRA-511 Phase 1b Signal-Seeking Study in Alzheimer's Disease Agitation

Core Insights - Neumora Therapeutics announced positive results from its Phase 1b study of NMRA-511, demonstrating a clinically meaningful reduction in agitation symptoms in Alzheimer's disease patients, particularly those with elevated anxiety [2][3][10] - NMRA-511 showed a 15.7% reduction in mean CMAI total score, indicating a significant clinical effect size [1][10] - The drug exhibited a favorable safety and tolerability profile, with low rates of treatment discontinuation due to adverse events [1][10] Study Design and Results - The Phase 1b study included two parts: Part A focused on healthy elderly adults, while Part B involved 80 patients with Alzheimer's disease agitation [4] - In Part B, NMRA-511 demonstrated a placebo-adjusted change of -2.6 and -2.1 in CMAI total score at Weeks 6 and 8, respectively, with a Cohen's d effect size range of 0.20 – 0.23 [10] - Among patients with elevated anxiety, NMRA-511 showed a more pronounced effect with a -7.6 and -5.6 placebo-adjusted change at Weeks 6 and 8, respectively, resulting in a Cohen's d effect size range of 0.51 – 0.64 [10] Future Plans - Neumora plans to initiate a multiple ascending dose expansion cohort for NMRA-511 in 2026 to evaluate higher doses [1][6] - The company aims to develop an extended-release formulation for once-daily dosing and to start a Phase 2/3 dose-ranging study [10] - A conference call is scheduled for January 5, 2026, to discuss these developments [6] About NMRA-511 - NMRA-511 is a highly potent and selective antagonist of the vasopressin 1a receptor (V1aR), showing over 3,000-fold selectivity compared to V1b and V2 receptors [7] - The drug is positioned to address agitation symptoms in Alzheimer's disease and has potential applications in various neuropsychiatric disorders [7] About Neumora - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for brain diseases [8] - The company's pipeline includes seven programs targeting a range of prevalent diseases with unmet medical needs [8]