Neurocrine Biosciences Updates ERUDITE™ Phase 2 Data on Luvadaxistat for Cognitive Impairment in Schizophrenia

Neurocrine Biosciences, Inc., a leading biopharmaceutical company, recently announced disappointing results from its ERUDITE™ Phase 2 clinical study of luvadaxistat (NBI-1065844). The investigational compound aimed to treat cognitive impairment in patients with schizophrenia but failed to meet its primary endpoint. This setback has led the company to shift its focus toward Phase 3 clinical development of other promising candidates.

The ERUDITE study was the second Phase 2 trial for luvadaxistat. Unfortunately, unlike the initial INTERACT™ study, the ERUDITE trial did not produce statistically significant improvements in cognitive measures. Variability in the cognitive measures across the study population and potential imbalances in baseline characteristics of the enrolled subjects were cited as contributing factors to the disappointing results.

In the earlier INTERACT study, luvadaxistat showed promise. Administering 50 mg of the compound led to statistically significant improvements in cognitive assessments. These assessments included the Brief Assessment of Cognition in Schizophrenia (BACS) and the Schizophrenia Cognition Rating Scale (SCoRS). This study marked the first time that both cognitive measures and functional improvements were demonstrated within a single study.

"This outcome is disappointing, but it underscores the challenges in developing treatments for cognitive impairment in schizophrenia," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "Given these hurdles, we have decided to halt the development of luvadaxistat. Instead, we will direct our resources toward advancing NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder into Phase 3 clinical development."

Luvadaxistat is an investigational, oral, selective inhibitor with a high binding affinity to d-amino acid oxidase (DAAO). This enzyme metabolizes D-Serine, a primary NMDA receptor co-agonist in the brain's limbic region. NMDA receptor hypofunction on PV+ gamma-aminobutyric acid (GABA) interneurons results in cortical or hippocampal glutamate neuron disinhibition, contributing to cognitive impairment in schizophrenia.

The ERUDITE™ Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of luvadaxistat in adults with cognitive impairment associated with schizophrenia. Neurocrine Biosciences had acquired the rights to develop and commercialize luvadaxistat from Takeda Pharmaceutical Company, Ltd.

Schizophrenia is a severe and complex mental health condition characterized by a heterogeneous set of symptoms. The disorder is thought to result from genetic and environmental factors and affects over 20 million people worldwide, according to the World Health Organization. In the United States alone, the annual costs associated with schizophrenia exceed $150 billion. Approximately 80% of individuals with schizophrenia experience cognitive impairment.

Neurocrine Biosciences is dedicated to developing therapies for individuals suffering from neurological, neuroendocrine, and neuropsychiatric disorders. The company has a diverse portfolio, including FDA-approved treatments for conditions such as tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis, and uterine fibroids. Neurocrine’s pipeline includes multiple compounds in mid to late-stage clinical development.

For three decades, Neurocrine Biosciences has leveraged its expertise in neuroscience to address complex conditions. The company remains committed to discovering and developing life-changing treatments for patients with significant unmet medical needs.

As Neurocrine Biosciences moves forward, the focus will be on the Phase 3 development of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder, aiming to bring new hope to patients in these critical areas.

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