Nxera Pharma Co., Ltd.
Announcement of Subject Dosing Start in Phase 2 Trial of NBI-1117570 for Adult Schizophrenia Patients by Partner NeuroCline, Inc.
Partner NeuroCline, Inc. has initiated a Phase 2 trial of NBI-1117570 targeting adult schizophrenia patients and received a 22.5 million USD milestone payment.
Key Figures
- Milestone Payment Amount: 22.5 million USD (approximately 3,574 million JPY)
- Scheduled Revenue Recognition Period: Fiscal Year Ending December 2026 Q1
- Planned Patient Enrollment for Phase 2 Trial: Approximately 120 patients
AI要約
Start of Phase 2 Trial and Milestone Receipt
NeuroCline, Inc., a partner of Nexera Pharma, has commenced the Phase 2 trial of NBI-1117570 for adult schizophrenia patients and initiated dosing of the first subject. Accordingly, under the contract, a milestone payment of 22.5 million USD (approximately 3,574 million JPY) was received, which is scheduled to be recorded as revenue in the first quarter of the fiscal year ending December 2026. NBI-1117570 is an oral selective muscarinic M1/M4 receptor agonist developed utilizing Nexera Pharma’s proprietary drug discovery platform NxWave™.
Trial Overview and Future Outlook
This Phase 2 trial is a double-blind, placebo-controlled study evaluating efficacy, safety, and tolerability in approximately 120 adult schizophrenia patients requiring inpatient treatment. The primary endpoint is the change in the total PANSS score at Day 35, with treatment-emergent adverse events as secondary endpoints. The consolidated earnings guidance disclosed on February 13, 2026, already incorporates the impact of this development, and further updates on the progress of the muscarinic agonist portfolio are expected moving forward.