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

• NBI-1117568 is an oral, muscarinic M4 selective receptor agonist discovered by Nxera advancing through clinical development under a multi-program collaboration with Neurocrine
• For more information, please read Neurocrine’s announcement (link)

Tokyo, Japan and Cambridge, UK, 1 May 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) today announces that its partner Neurocrine Biosciences Inc. (“Neurocrine”) has initiated a Phase 3 registrational program to evaluate the efficacy, safety and tolerability of NBI-1117568 (NBI-’568), an investigational oral muscarinic M4 selective orthosteric agonist, as a potential treatment for schizophrenia. Positive top-line data for the Phase 2 clinical study in adults with schizophrenia were reported in August 2024.

Chris Cargill, President and CEO of Nxera Pharma, commented: “Today’s news marks a pivotal milestone for Nxera with NBI’568 becoming the first NxWave™-designed molecule to enter a Phase 3 clinical trial. NBI-’568 is the most advanced candidate from a portfolio of muscarinic agonists discovered by Nxera, licensed to Neurocrine and advancing through clinical development. These candidates were designed using our NxWave™ platform with specific attributes to address the complex needs of patients with neuropsychiatric disorders, who remain hugely underserved by current treatment options. The expertise and commitment that Neurocrine has demonstrated in progressing NBI-’568 to this advanced stage and to our partnership as a whole has been inspirational. We look forward to reporting further updates as Neurocrine advances NBI-‘568 through its Phase 3 program and continues to make progress with the broader muscarinic portfolio.”

The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-’568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale.

There is no milestone payment payable by Neurocrine to Nxera associated with the start of the Phase 3 trial. A US$15 million milestone payment is due upon dosing of the first patient in the Phase 3 study. Nxera will make a separate announcement when this milestone event is reached.