NBI-1117567 / Neurocrine Biosciences, Nxera Pharma - LARVOL DELTA

Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P2 trial • Alzheimer's Disease • CNS Disorders

Nxera Pharma…announces that its partner Neurocrine Biosciences Inc. ('Neurocrine') has received IND Acceptance from the U.S. Food and Drug Administration (FDA) for a Phase 2 study of NBI-1117567 ('NBI-’567') for Alzheimer's cognition (GlobeNewswire) - "Nxera will receive an IND Acceptance milestone payment of US$10 million from Neurocrine pursuant to the agreement. The milestone payment is expected to be recognised in full as revenue in Q3 FY2026....NBI-1117567 is an investigational oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera and advancing through clinical development under a multi-program collaboration with Neurocrine."

Financing • IND • New P2 trial • Alzheimer's Disease

Progress with partnered programs (GlobeNewswire) - "NBI-1117567 (an M1-preferring agonist): a Phase 2 study targeting Alzheimer's cognition expected to begin during 2026; NBI-1117569 (a dual M1/M4 agonist): results from a Phase 1 study targeting Alzheimer's psychosis expected to be announced in 2027." "

New P2 trial • P1 data • Alzheimer's Disease

Details of Neurocrine's transformed R&D engine, designed to deliver at least four new Phase 1 and two Phase 2 programs per year by focusing on genetically or clinically validated mechanisms of action were shared during today's event. Highlighted programs include: (PRNewswire) - "NBI-'569, a dual M1 / M4 agonist for Alzheimer's psychosis, and NBI-'567, an M1 preferring agonist for Alzheimer's cognition and Lewy body dementia; Next-generation VMAT2 inhibitors; NBI-'890 and NBI-'675, engineered for increased half-life and potency and decreased solubility, and which provide the potential for long-acting injectable administration across multiple central nervous system indications; A suite of differentiated assets for better quality weight loss, including NBIP-'2118, a CRF2 agonist expected to enter Phase 1 development in the first half of 2026....Neurocrine plans to provide update on its emerging early-stage Neurology and Immunology pipeline in 2026."

New P1 trial • Pipeline update • Alzheimer's Disease • Dementia • Lewy Body Disease • Obesity

Nxera Pharma Operational Highlights and Consolidated Results for the First Quarter 2025 (GlobeNewswire) - "Neurocrine Biosciences, Inc. outlined clinical development plans for the partnered muscarinic agonist portfolio in 2025, including Initiation of Phase 3 registrational studies with NBI-1117568 (an oral, muscarinic M4-selective agonist) in schizophrenia in 1H 2025; Initiation of a Phase 2 study with NBI-1117568 in bipolar mania in 2H 2025; Initiation of a Phase 2 study with NBI-1117570 (a dual M1 / M4 agonist) in schizophrenia in 2H 2025; Data readouts for NBI-1117570, NBI-1117567 (M1-preferring), and NBI-1117569 (M4-preferring) expected in 2025, all of which are being advanced in Phase 1 trials targeting neurological and neuropsychiatric conditions."

Clinical data • New P2 trial • New P3 trial • CNS Disorders • Schizophrenia