Neumora Therapeutics, Inc. (NASDAQ:NMRA) on Monday shared results from its Phase 1b signal-seeking study of NMRA-511 for Alzheimer’s disease (AD) agitation.
NMRA-511 demonstrated a clinically meaningful effect size in people with AD agitation.
In the study, NMRA-511 demonstrated a favorable tolerability and safety profile with no reports of somnolence or sedation.
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The Phase 1b study investigated NMRA-511 in healthy elderly adult participants (Part A) as well as people with agitation associated with dementia due to AD (Part B).
Key Findings
Part B of the Phase 1b study delivered encouraging results.
Patients treated with NMRA-511 demonstrated a -2.6 and -2.1 placebo-adjusted change from baseline on CMAI total score at Weeks 6 and 8, respectively.
Cohen-Mansfield Agitation Inventory (CMAI) is a clinically validated scale measuring the frequency of 29 agitated behaviors.
In the elevated anxiety population, NMRA-511 demonstrated a -7.6 and -5.6 placebo-adjusted change from baseline on CMAI total score at Weeks 6 and 8, respectively.
NMRA-511 demonstrates a favorable tolerability and safety profile. Treatment-emergent adverse events (TEAEs) were typically mild to moderate in severity, and there were low treatment discontinuations due to TEAEs (2.5%).
Next Steps
Neumora plans to advance NMRA-511 by launching a multiple ascending dose extension study at higher doses in 2026, developing an extended-release formulation to support once-daily dosing in 2026, and initiating a Phase 2/3 dose-ranging study.
On Monday, Neumora also announced that it plans to increase enrollment in each of the KOASTAL studies of navacaprant in major depressive disorder, targeting up to 25% enrollment beyond the original target of 332.
The company expects a joint topline data readout for both KOASTAL-2 and KOASTAL-3 in the second quarter of 2026.
NMRA Price Action: Neumora Therapeutics shares were up 2.11% at $1.69 at the time of publication on Monday, according to Benzinga Pro data.
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