Nxera Pharma Co (TYO:4565) partner Neurocrine Biosciences has initiated a Phase 3 trial for NBI-1117568, an oral muscarinic M4 receptor agonist, for treating schizophrenia, according to a Thursday filing on the Tokyo Stock Exchange.
The trial follows positive Phase 2 results reported in August 2024, showing a significant reduction in symptoms.
The global, placebo-controlled trial will enroll around 280 patients with acute schizophrenia symptoms. The primary endpoint is the reduction of PANSS score, with secondary endpoints focusing on clinical severity.
No milestone payment is due at trial start, but a $15 million payment will be triggered when the first patient is dosed.
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