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Neurocrine Biosciences Inc.’s (NASDAQ:NBIX) ERUDITE phase two clinical study of investigational compound luvadaxistat (NBI-1065844) failed to meet its primary endpoint as a potential treatment to improve cognitive impairment in schizophrenia patients.
It failed to replicate the cognitive endpoint data seen in the earlier INTERACT study due in part to the large variability seen in the cognitive measures across the population studied and a potential imbalance in the baseline characteristics of subjects enrolled across the treatment arms.
In the INTERACT study, 50 mg luvadaxistat resulted in a statistically significant improvement in the measure of cognition on the Brief Assessment of Cognition in Schizophrenia (BACS) and cognitive performance on the Schizophrenia Cognition Rating Scale (SCoRS).
The INTERACT study was the first to demonstrate statistical significance for both cognitive measures and function within a single study.
The company stated it was disappointed that luvadaxistat did not meet the primary endpoint in this study and it understood the challenges and hurdles that exist in identifying potential medicines for the treatment of cognitive impairment in schizophrenia.
Neurocrine Biosciences will halt further development of luvadaxistat and instead will focus on the advancement into phase three development of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder.
In August, Neurocrine Biosciences shared topline data for its phase one study of NBI-1117568 (NBI-‘568) in adults with schizophrenia.
The new data showed that the once-daily 20 mg dose of NBI-‘568 induced an average 18.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks, compared to 10.8 points in the placebo group.
William Blair noted further value can be unlocked through the expanding Ingrezza business, the anticipated near-term launch of crinecerfont for treating congenital adrenal hyperplasia (CAH), with PDUFA dates set for Dec. 29 and 30, 2024, and the company's mid-stage portfolio.
The analyst reiterated the Outperform rating on Neurocrine.
NBIX Price Action: Neurocrine Biosciences stock is up 0.82% at $122.27 at last check Friday.
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Posted In: NBIX
