Nxera Pharma's Partner Neurocrine Biosciences Initiates Phase 3 Registrational Program of NBI-1117568 as a Potential Treatment for Adults with Schizophrenia

Core Viewpoint - Nxera Pharma's partner Neurocrine Biosciences has initiated a Phase 3 clinical trial for NBI-1117568, an investigational treatment for schizophrenia, following positive Phase 2 results [1][6]. Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet medical needs, leveraging its NxWave™ discovery platform [11][12]. - The company has a pipeline of over 30 active programs targeting neurology, neuropsychiatry, metabolic diseases, and immunology [12]. Clinical Development - NBI-1117568 is the first oral muscarinic M4 selective orthosteric agonist in clinical development for schizophrenia, with a unique mechanism aimed at improving safety and efficacy [5][8]. - The Phase 3 study will enroll approximately 280 patients and will evaluate the drug's efficacy using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression of Severity (CGI-S) scale [2][6]. Financial Aspects - No milestone payment is due from Neurocrine to Nxera at the start of the Phase 3 trial, but a US$15 million milestone payment is expected upon dosing the first patient [3]. Market Context - Schizophrenia affects approximately 24 million people globally, with annual costs exceeding $150 billion in the U.S., highlighting the significant need for effective treatments [10].