Neurocrine Biosciences has reported positive top-line results from its Phase II clinical study of NBI-1117568, an investigational oral treatment for schizophrenia.
Named NBI-‘568-SCZ2028, the study met its primary endpoint with a significant reduction in schizophrenia symptoms at a once-daily 20mg dose.
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The trial also demonstrated a clinically meaningful and statistically significant decline in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week six.
The placebo-adjusted mean reduction was 7.5 points, accompanied by an 18.2-point reduction from baseline.
Additional endpoints also showed significant improvements, including the Clinical Global Impression of Severity (CGI-S) scale and Marder Factor Scores for both positive and negative symptom changes.
Regarding safety, NBI-1117568 was found to be generally well tolerated across all the tested doses in the Phase II trial.
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By GlobalDataThe rates of treatment discontinuation linked to adverse events were similar to the placebo.
Somnolence, dizziness, and headache were reported to be the most common adverse events reported in the trial.
Gastrointestinal issues, such as nausea and constipation, and cardiovascular-related events, were infrequent and considered not clinically significant at any dose.
Most notably, NBI-1117568 did not result in a greater increase in weight compared to the placebo, and there were few reports of extrapyramidal symptoms.
Neurocrine Biosciences chief medical officer Eiry Roberts said: “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.
“We recognise the significant need for new and innovative medicines to treat schizophrenia and look forward to advancing NBI-‘568, the first M4 selective agonist, into Phase III development early next year.”
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.
