Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1117568 in Adults with Schizophrenia

https://www.morningstar.com/news/pr-newswire/20240828la92574/neurocrine-biosciences-reports-positive-phase-2-data-for-nbi-1117568-in-adults-with-schizophrenia

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

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.

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Neurocrine Biosciences has achieved its hoped-for profile in a phase 2 schizophrenia trial, delivering its targeted level of efficacy with a lower rate of gastrointestinal adverse events than Bristol Myers Squibb’s KarXT. But the biotech only saw efficacy at the lowest dose—the three higher doses all failed.

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The lowest dose outperformed higher doses of the drug - a result that prompted investor questions over whether or not the data could be reproduced in larger trials