Neurocrine’s NBI-1117568 shows positive Phase 2 results in schizophrenia

Neurocrine announced positive top-line data for its Phase 2 clinical study of NBI-1117568 in adults with schizophrenia. NBI-‘568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. The NBI-‘568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose. It demonstrated a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale total score at Week 6 with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline. The once-daily 20 mg dose also demonstrated a statistically significant improvement for additional endpoints. The company intends to advance NBI-‘568 into Phase 3 development early next year. NBI-‘568 was generally safe and well tolerated at all doses studied in the Phase 2 clinical trial. Adverse events with the highest incidence were somnolence, dizziness, and headache. In addition to NBI-‘568, Neurocrine Biosciences has a portfolio of assets in clinical development that selectively target muscarinic receptors.