Neurocrine Biosciences has announced positive top-line results from its Phase II clinical study of NBI-1117568, an investigational oral treatment for schizophrenia. The trial, named NBI-‘568-SCZ2028, met its primary endpoint by demonstrating a significant reduction in schizophrenia symptoms at a once-daily 20mg dose. This outcome underscores the potential of NBI-1117568 as a novel therapeutic option for individuals grappling with this challenging mental health condition.
Significant Symptom Reduction
The Phase II trial showcased a clinically meaningful and statistically significant decline in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week six. Specifically, the placebo-adjusted mean reduction was 7.5 points, accompanied by an 18.2-point reduction from baseline. These results indicate a substantial improvement in the overall symptom burden experienced by patients.
Additional Positive Endpoints
Beyond the primary endpoint, the study also revealed significant improvements in additional key measures, including the Clinical Global Impression of Severity (CGI-S) scale and Marder Factor Scores for both positive and negative symptom changes. These findings further support the efficacy of NBI-1117568 in addressing the multifaceted symptoms of schizophrenia.
Safety and Tolerability Profile
Regarding safety, NBI-1117568 was found to be generally well tolerated across all tested doses in the Phase II trial. Treatment discontinuation rates linked to adverse events were similar to the placebo group. The most common adverse events reported were somnolence, dizziness, and headache. Notably, NBI-1117568 did not result in a greater increase in weight compared to the placebo, and there were few reports of extrapyramidal symptoms, addressing critical concerns associated with many existing antipsychotic medications.
Future Development
Neurocrine Biosciences chief medical officer Eiry Roberts stated, “This Phase II dose-finding study delivered on our goal of identifying a once-daily, well tolerated dosing regimen, with a compelling and competitive benefit-risk profile.” The company plans to advance NBI-1117568, described as the first M4 selective agonist, into Phase III development early next year, marking a significant step forward in its clinical development program.
Neurocrine's Muscarinic Receptor Portfolio
Neurocrine Biosciences’ portfolio extends beyond NBI-1117568, featuring several other assets targeting muscarinic receptors. The company is also developing a suite of muscarinic agonists, including NBI-1117567, NBI-1117569, and NBI-1117570, the rights for which were acquired from Nxera Pharma. In addition, Neurocrine is advancing NBI-1076986, a selective M4 antagonist developed in-house.
