Neurocrine Adjusts Course Following Luvadaxistat Study Setback
Neurocrine Biosciences Adjusts Focus After Luvadaxistat Trial
Neurocrine Biosciences Inc. (NASDAQ: NBIX) has recently recalibrated its strategic direction following the results of the ERUDITE phase two clinical trial of luvadaxistat (NBI-1065844). This investigational treatment for cognitive impairment in schizophrenia did not meet its primary endpoint, prompting the company to reassess its approach.
Challenges Faced in the ERUDITE Study
The clinical trial faced significant difficulties, failing to replicate the positive cognitive outcomes demonstrated in the previous INTERACT study. Variability among cognitive measures across the studied population and imbalanced baseline characteristics of subjects were potential contributing factors to this outcome.
Insights from Previous Studies
In the past, the INTERACT study showed promising results, with a 50 mg dose of luvadaxistat leading to statistically significant enhancements in cognition as measured by the Brief Assessment of Cognition in Schizophrenia (BACS) and performance metrics from the Schizophrenia Cognition Rating Scale (SCoRS).
Decision to Halt Development of Luvadaxistat
Given the disappointing results, Neurocrine has decided to discontinue further development of luvadaxistat. Instead, the company will shift its focus toward advancing NBI-1117568 and NBI-1065845, which are being developed for schizophrenia and major depressive disorder, respectively.
Promising Results for NBI-1117568
Recent topline data from the phase one study of NBI-1117568 highlighted its potential, showcasing an average reduction of 18.2 points on the Positive and Negative Syndrome Scale (PANSS) after six weeks at a 20 mg once-daily dosage, in contrast to a 10.8-point improvement in the placebo group. Such results bolster confidence in the candidate's effectiveness and highlight the company's ongoing commitment to identify effective therapies for mental health conditions.
Future Prospects and Strategic Growth
Analysts are optimistic about the company's growth potential, particularly with the expanding Ingrezza portfolio and the anticipated launch of crinecerfont aimed at treating congenital adrenal hyperplasia (CAH). With pivotal dates set for late 2024, Neurocrine's future endeavors are positioned to unlock further value within the biopharmaceutical landscape.
Stock Performance Overview
As of the latest check, shares of Neurocrine Biosciences are experiencing a slight uptick of 0.82%, trading at approximately $122.27. This indicates investor response amidst the transitional phase the company is navigating.
Frequently Asked Questions
What led to the decision to discontinue luvadaxistat?
The clinical study did not meet its primary endpoint, leading to uncertainties regarding its efficacy in treating cognitive impairment in schizophrenia.
What alternatives is Neurocrine focusing on after luvadaxistat?
Neurocrine is shifting its focus towards the development of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder.
What were the results of the prior INTERACT study?
The INTERACT study demonstrated a statistically significant improvement in cognitive measures, contributing to optimism about luvadaxistat’s potential at that time.
How has the market responded to Neurocrine's stock following these developments?
Shares of Neurocrine have seen a slight increase, indicating some investor confidence despite the challenges faced.
What are the upcoming milestones for Neurocrine?
Anticipated milestones include the development of crinecerfont for CAH, with pivotal dates set for late 2024.
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