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Neurocrine Biosciences Presents New Positive Data from Phase 2 Study of NBI-1117568 in Adults with Schizophrenia at American Society of Clinical Psychopharmacology 2025
SAN DIEGO, May 28, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of data from the Phase 2 study of
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, May 28, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of data from the Phase 2 study of NBI-1117568 in adults with schizophrenia, which showed a significant improvement in symptoms and overall severity and highlighted new data on the safety and tolerability of the treatment. NBI-1117568 is the first and only investigational oral muscarinic M4 selective orthosteric agonist in clinical development as a potential treatment for schizophrenia. These results were shared as an oral presentation and poster at the American Society of Clinical Psychopharmacology 2025 Annual Meeting in Scottsdale, Arizona.\n\n \n \n \n \n \n \n\n \n\"Traditional treatment approaches for schizophrenia can lead to significant short- and long-term challenges and often result in discontinuation of therapy. Given these challenges, there is a continued need for new, effective and tolerable treatment options,\" said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. \"This compound is promising as it is a direct and selective muscarinic M4 receptor agonist, which is believed to be a key regulator of neurotransmitters impacted by schizophrenia, and we look forward to advancing its development in the Phase 3 registrational program.\"\nIn this dose-finding study, adults aged 18 to 55 years with schizophrenia were randomized (2:1) to either NBI-1117568 (dose arms: 20 mg, 40 mg, 60 mg once daily; 30 mg twice daily) or placebo. Other antipsychotics were not allowed during the study. The study consisted of a six-week, double-blind, placebo-controlled period and a two-week safety follow-up.\nNBI-1117568 was generally safe and well tolerated at all doses studied, with treatment discontinuation rates due to adverse events similar between NBI-1117568 and placebo. Adverse events with the highest incidence for NBI-1117568 compared with placebo were somnolence (10.7% vs 2.9%, respectively) and dizziness (9.3% vs 1.4%). Increases in heart rate were transient, attenuated over the course of treatment, and not clinically meaningful. No weight gain was associated with the NBI-1117568 treatment groups relative to placebo.\nThe primary endpoint was the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 6. The study showed statistically significant improvements in PA...