Neumora Therapeutics’ oral Alzheimer’s disease agitation drug has shown benefit, reducing agitation, in a Phase Ib trial.
In the study (NCT06546995), the 71 patients from the modified analysis set (MAS) treated with twice-daily NMRA-511 saw a clinically meaningful 2.6 and 2.1 point placebo-adjusted reduction on the Cohen-Mansfield Agitation Inventory (CMAI) scores at weeks six and eight, respectively.
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In the elevated anxiety population, which included 36 patients, NMRA-511 demonstrated a 7.6 and 5.6 placebo-adjusted reduction on CMAI scores at weeks six and eight.
The CMAI is a scale used to measure agitation in elderly individuals with dementia by assessing the frequency of 29 specific agitated or aggressive behaviours.
In the study, NMRA-511 demonstrated a favourable tolerability and safety profile with no reports of somnolence or sedation. NMRA-511 is an oral, highly potent, brain-penetrant and selective antagonist of the vasopressin 1a receptor (V1aR).
Dr Anton Porsteinsson, director of the Alzheimer’s Disease Care, Research and Education Program (AD-CARE) at the University of Rochester School of Medicine and Dentistry, said: “Alzheimer’s disease agitation is a common and distressing symptom in Alzheimer’s dementia that can significantly impact the quality of life for both patients and caregivers. It is associated with increased morbidity and mortality and earlier placement in long-term care facilities. Existing treatment options are often limited by modest efficacy, tolerability and safety concerns, leaving vast unmet need for therapies that reduce agitation, and improve outcomes without significant adverse effects.”
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By GlobalDataBased on the Phase Ib data, Neumora will initiate a multiple ascending dose (MAD) extension study in 2026, with plans to later initiate a Phase II/III dose-ranging trial.
The company is also hoping to develop a formula to improve dosing to once per day in 2026.
Otsuka’s Rexulti (brexpiprazole) is the only drug approved for Alzheimer’s disease agitation, having gained US Food and Drug Administration (FDA) approval in 2023. GlobalData, the parent company of Clinical Trials Arena, predicts that sales in Alzheimer’s disease agitation will peak in 2028, reaching $436m.
Otsuka was hoping to get a second candidate on the market with AVP-786; however, the drug failed to show benefit in a Phase III trial and development has been terminated.
Axsom is waiting on a decision by the FDA on its drug, AXS-05 (dextromethorphan/bupropion), an oral, investigational NMDA receptor antagonist, in Alzheimer’s disease agitation. The drug is already approved in major depressive disorder (MDD). Antipsychotics, like risperidone and haloperidol, are used off-label in certain regions, as well as selective serotonin reuptake inhibitors (SSRIs).
