The Once-Daily 20 mg Dose Met the Primary Endpoint, Demonstrating a Statistically Significant 7.5-Point Improvement (p=0.011, 0.
61 Effect Size) in the PANSS Total Score Compared to Placebo at Week 6 with an 18.2-Point PANSS Total Score Improvement from Baseline The Once-Daily 20 mg Dose Met Additional Endpoints, Demonstrating Statistically Significant Improvements in Clinical Global Impression of Severity Scale and Marder Factor Score Positive Symptom Change and Negative Symptom Change NBI-'568 Was Generally Safe and Well Tolerated at All Doses Studied The Once-Daily 20 mg Dose Efficacy, Safety and Tolerability Phase 2 Results Support Advancement to Phase 3 in Schizophrenia in Early 2025 Company to Host Conference Call with Management at 8 a.m.
EDT SAN DIEGO , Aug. 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced positive top-line data for its Phase 2 clinical study of NBI-1117568 (NBI-'568) 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 (PANSS) total score at Week 6 with a placebo-adjusted mean reduction of 7.
5 points (p=0.011 and effect size of 0.61) and an 18.
2-point reduction from baseline. The on.