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

Core Insights - Nxera Pharma's partner Neurocrine Biosciences has initiated a Phase 3 registrational program for NBI-1117568, an investigational oral muscarinic M4 selective orthosteric agonist aimed at treating schizophrenia, following positive Phase 2 results reported in August 2024 [1][2][6] Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet medical needs, utilizing its NxWave™ discovery platform to advance a pipeline of over 30 active programs [12][13] - The company has a strategic partnership with Neurocrine, which is advancing NBI-1117568 through clinical development [2][7] Clinical Development - The Phase 3 study is a global double-blind, placebo-controlled trial targeting approximately 280 patients with schizophrenia experiencing acute exacerbation or relapse of symptoms, with primary and secondary endpoints focused on PANSS and CGI-S scales [2][6] - NBI-1117568 has shown a statistically significant reduction in PANSS total score with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline at Week 6 [8] 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 United States, highlighting the significant need for effective treatments [11]