Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1117568 in Adults with Schizophrenia

NBI-1117568 is an Investigational, First-in-Class, Muscarinic M4 Selective Agonist

Excerpt from the Press Release:

SAN DIEGO, Oct. 27, 2022 /PRNewswire/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced the first patient has been randomized for its Phase 2 placebo-controlled, inpatient clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of investigational compound NBI-1117568 in adults with schizophrenia. NBI-1117568 is an investigational, muscarinic M4 selective acetylcholine receptor agonist believed to be a key regulator of neurotransmitters impacted by schizophrenia.

“Initiation of this Phase 2 study for NBI-1117568 brings forward a first-in-class, orally active, highly selective investigational M4 agonist as a potential treatment for schizophrenia, a serious and complex psychiatric syndrome impacting 0.5-1.0% of the U.S. population and approximately 20 million people worldwide,” said Eiry W. Roberts, M.D., Chief Medical Officer. “The differentiated profile of NBI-1117568 in terms of its selectivity as an M4 agonist may provide an opportunity for efficacy in treating the symptoms of psychosis with a potentially different side effect profile.”

The NBI-1117568 Phase 2 multi-arm, multi-stage study will enroll approximately 200 adults and is being conducted at 15 centers throughout the United States. The placebo-controlled study will evaluate multiple active dose levels of NBI-1117568. The primary outcome measure will be the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 6. For more information about this study (NBI-1117568-SCZ2028), visit ClinicalTrials.gov

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