Neurocrine Biosciences (NBIX) has begun registering prospective patients for a phase 3 trial to evaluate the efficacy, safety and tolerability of its NBI-1117568 drug candidate to treat adults with a primary diagnosis of schizophrenia, the company said on Wednesday morning.
The new, doubled-blinded study is expected to enroll around 280 patients who are experiencing an acute exacerbation or relapse of schizophrenia symptoms and will receive a once-daily 20 milligram dose of the investigational oral muscarinic M4 selective orthosteric agonist.
The upcoming trial will have a primary endpoint of the reduction from baseline as measured by the Positive and Negative Syndrome Scale and a key secondary endpoint of improvement on the Clinical Global Impression of Severity scale.
During phase 2 testing, top-line data reported last August showed clinically meaningful and statistically significant reduction from baseline on the PANSS total score after six weeks compared with patients treated with a placebo.
Neurocrine shares were little changed during recent Wednesday trading.
Price: 106.85, Change: -0.39, Percent Change: -0.36
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