Neurocrine reports data from Phase II study for the treatment of schizophrenia

The Phase II clinical trial evaluated NBI-1117568 as an oral treatment for schizophrenia. Image credit: NTshutterth/Shutterstock.

Neurocrine Biosciences has reported positive topline results from its Phase II clinical trial of NBI-1117568, an experimental oral drug for the treatment of schizophrenia.

The study, called NBI-'568-SCZ2028, met its primary endpoint with a significant reduction in schizophrenia symptoms at a once-daily dose of 20 mg.

The study also showed a clinically meaningful and statistically significant decrease in the total Positive and Negative Syndrome Scale (PANSS) score from baseline to week six.

The placebo-corrected mean reduction was 7.5 points, accompanied by a reduction of 18.2 points from baseline.

Additional endpoints also showed significant improvements, including the Clinical Global Impression of Severity (CGI-S) scale and the Marder factor scores for both positive and negative symptom changes.

In terms of safety, NBI-1117568 was generally well tolerated at all doses tested in the Phase II study.

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Treatment discontinuation rates due to adverse events were comparable to those for placebo.

Drowsiness, dizziness and headache were the most commonly reported side effects in the study.

Gastrointestinal problems such as nausea and constipation as well as cardiovascular events occurred rarely and were not considered clinically significant at any dose.

Of particular note is that NBI-1117568 did not result in greater weight gain compared to placebo and there were few reports of extrapyramidal symptoms.

Eiry Roberts, Chief Medical Officer of Neurocrine Biosciences, said: “With this Phase II dose-finding study, we have achieved our goal of identifying a once-daily, well-tolerated dosing regimen with a compelling and competitive benefit-risk profile.

“We recognize the significant need for new and innovative medicines to treat schizophrenia and look forward to advancing NBI-'568, the first selective M4 agonist, into Phase III development early next year.”

Neurocrine Biosciences' portfolio extends beyond NBI-1117568 and includes several other compounds targeting muscarinic receptors.

The company is also developing a number of muscarinic agonists, including NBI-1117567, NBI-1117569 and NBI-1117570, the rights to which have been acquired by Nxera Pharma.

In addition, Neurocrine is further developing NBI-1076986, a proprietary selective M4 antagonist.

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Neurocrine reports data from Phase II study for the treatment of schizophrenia

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Neurocrine reports data from Phase II study for the treatment of schizophrenia

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