Neumora Therapeutics, Inc. (NASDAQ:NMRA), a clinical-stage biopharmaceutical company focused on developing novel therapies for neuropsychiatric disorders and neurodegenerative diseases, today reported positive topline results from a Phase 1b signal-seeking study evaluating NMRA-511 as a potential treatment for agitation in patients with Alzheimer's disease.
The proof-of-concept trial demonstrated a clinically meaningful 15.7-point mean reduction from baseline on the Cohen-Mansfield Agitation Inventory (CMAI) total score.
In a pre-specified subgroup of patients with elevated anxiety at baseline, NMRA-511 showed larger placebo-adjusted improvements, with differences of -7.6 points at Week 6 and -5.6 points at Week 8, corresponding to Cohen's d effect sizes of 0.51 to 0.64.
NMRA-511 exhibited a favorable safety and tolerability profile, with only 2.5% of patients discontinuing treatment due to treatment-emergent adverse events (TEAEs).
The study was designed as a signal-seeking trial and was not powered to detect statistical significance.
Agitation is a common and distressing symptom in Alzheimer's disease, affecting a significant portion of patients and representing a major area of unmet medical need with limited approved treatment options.
Neumora plans to advance NMRA-511 with multiple ascending dose expansion studies and formulation development work aimed at achieving once-daily extended-release dosing, with activities continuing throughout 2026.
These encouraging early data support further exploration of NMRA-511's potential in this challenging indication.