Nxera Pharma Co., Ltd. has been notified by its partner Neurocrine Biosciences Inc. that NBI-1117568, an oral selective muscarinic M4 receptor agonist being advanced in Phase 2 clinical trials by Neurocrine for the treatment of schizophrenia and other neuropsychiatric disorders, has successfully completed a long-term preclinical toxicity program that meets US FDA requirements to allow for safe, chronic (i.e. long-term) dosing in future clinical trials. The achievement of this important safety development milestone triggers a $15 million payment to Nxera from Neurocrine. NBI-1117568 is the most advanced candidate from a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under the 2021 global collaboration with Neurocrine for the treatment of major neurological disorders.

These candidates have potential to address a range of neurological and neuropsychiatric conditions and include: NBI-1117568 (an M4 selective agonist) in Phase 2 trials with top-line data expected in H2 2024. NBI-1117570 (an M1/M4 selective dual agonist) in Phase 1, NBI-1117569 (an M4-preferring agonist) in Phase 1, NBI-1117567 (an M1-preferring agonist) expected to enter Phase 1 in 2024.