Neurocrine Halts Phase 2 Neuropsych Med after Data Validation Failure

Neurocrine has announced the cessation of further development of its drug luvadaxistat following disappointing results in a mid-stage clinical trial aimed at treating cognitive impairment in patients with schizophrenia. The company revealed in a Thursday update that luvadaxistat failed to duplicate the cognitive improvement outcomes observed in an earlier study due to significant variability in cognitive abilities among participants and imbalances in the baseline characteristics within the treatment group.

The recent trial sought to confirm the findings from a 2021 Phase 2 study, which showed that luvadaxistat enhanced cognitive abilities, a secondary endpoint. However, in that earlier study, the drug did not meet its primary endpoint, which was to improve the negative symptoms of schizophrenia. Negative symptoms are characterized by patients withdrawing or isolating themselves, while positive symptoms are more behavioral changes, such as hallucinations.

Following the failed trial, Neurocrine has removed luvadaxistat from its research and development pipeline, according to an updated R&D chart. Chief Medical Officer Eiry Roberts stated that the company would halt further development of luvadaxistat and reallocate resources to advance other neuropsychiatry candidates into Phase 3 trials. One such candidate is NBI-1117568, which showed positive results last month as a treatment for schizophrenia, though it did not fully meet the company's expectations. Specifically, NBI-1117568 achieved a 7.5-point improvement in schizophrenia symptoms compared to a placebo, slightly below the anticipated 8-point improvement.

Despite these setbacks, the treatment landscape for schizophrenia may be on the brink of significant changes. Bristol Myers Squibb's newly acquired KarXT is awaiting an FDA decision later this month, and AbbVie is progressing a schizophrenia treatment it acquired through the purchase of Cerevel Therapeutics.

Neurocrine plans to initiate a Phase 3 study for NBI-1117568 in early 2025. Additionally, the company is preparing to advance its NBI-1065845 candidate for the treatment of major depressive disorder.