Neurocrine Drops Schizophrenia Drug After Phase II Failure

Neurocrine Biosciences has decided to cease the development of its investigational drug, luvadaxistat, intended for treating schizophrenia. This decision follows disappointing results from a mid-stage clinical trial. The Phase II study, named ERUDITE, aimed to assess the efficacy of luvadaxistat in improving cognition among over 200 patients with schizophrenia. However, the trial failed to meet its primary endpoint, which was cognitive improvement from baseline.

Neurocrine did not disclose specific data from the study but stated that luvadaxistat was unable to replicate the positive cognitive outcomes observed in an earlier trial called INTERACT. In the INTERACT study, a 50-mg dose of luvadaxistat showed significant cognitive improvements using two different assessment tools. Neurocrine noted that the INTERACT trial was the first instance where statistical significance for cognitive measures and function was demonstrated within a single study.

The company attributed the failure of the ERUDITE study to considerable variability in cognitive measures among participants and a potential imbalance in baseline characteristics. Chief Medical Officer Eiry Roberts described the results as "disappointing" and announced that the company would halt further development of luvadaxistat. Instead, Neurocrine will redirect its resources to other neuropsychiatric projects, such as the Phase III development of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder.

BMO Capital Markets analyst Evan Seigerman commented on the inconsistencies between the trials, raising questions about the company's developmental strategy. He found it puzzling that baseline characteristics were left imbalanced, suggesting that this oversight diminishes optimism for Neurocrine's future efforts in the challenging field of schizophrenia treatment. Despite the setback, Seigerman anticipates only a minor impact on Neurocrine's shares, as cognitive impairment associated with schizophrenia was not a major concern for most investors.

This recent failure follows another concerning development for Neurocrine. Last month, the company reported that its other schizophrenia candidate, NBI-1117568, only showed significant symptom improvement at the lowest dose in a Phase II study. All other doses failed to meet the primary endpoint, leading to a 20% drop in Neurocrine's shares. Investors were disappointed by these mixed results.

In contrast, Neurocrine had a positive outcome earlier in the year with its drug candidate NBI-1065845 for major depressive disorder. The Phase II study of NBI-1065845, developed in collaboration with Takeda, showed significant symptom reduction at 28 days compared to placebo. This success offers a glimmer of hope for the company's ongoing efforts in addressing neuropsychiatric conditions.

Overall, the recent developments point to a challenging road ahead for Neurocrine Biosciences as it navigates the complexities of drug development in the neuropsychiatric field. While the discontinuation of luvadaxistat marks a setback, the company remains committed to advancing its other therapeutic candidates in the hopes of delivering effective treatments for schizophrenia and major depressive disorder.