• NBI-1117570 is an investigational oral, dual muscarinic M1/M4 selective receptor agonist discovered by Nxera advancing through clinical development under a multi-program collaboration with Neurocrine
• Nxera to receive US$22.5 million in milestone payments from Neurocrine

Nxera Pharma Co., Ltd.announces that its partner Neurocrine Biosciences Inc. (“Neurocrine”) has initiated and dosed the first patient(s) in a Phase 2 clinical study of NBI-1117570 (“NBI-’570”) in adults with schizophrenia. As a result, Nxera will receive milestone payments of US$22.5 million from Neurocrine pursuant to the agreement. The milestone payments will be recognised as revenue in Q1 FY2026. NBI-‘570 is an investigational, orally administered, dual muscarinic M1/M4 receptor agonist discovered using Nxera’s proprietary NxWave™ drug discovery platform.

Christopher Cargill, President and CEO of Nxera Pharma, commented: “The initiation of this Phase 2 study with NBI-‘570, the second NxWave™-designed compound in Neurocrine’s muscarinic agonist portfolio to advance into Phase 2 clinical trials, represents another important step forward in our highly productive collaboration. Schizophrenia remains an area of significant unmet medical need and we believe NBI-’570 has the potential to contribute meaningfully to improving outcomes for patients. We look forward to sharing further updates on progress across the muscarinic agonist portfolio.”

The Phase 2 study (NCT07288333) is a double-blind, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of NBI-‘570 in adult patients with schizophrenia requiring in-patient treatment. The study is expected to enroll approximately 120 patients. The primary endpoint is change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score, and the key secondary endpoint is treatment-emergent adverse events (TEAEs).