Neurocrine Biosciences has reported that its Phase II ERUDITE clinical trial of luvadaxistat did not achieve its primary endpoint in improving cognitive impairment in schizophrenia patients.
The randomised, parallel-group, double-blind, placebo-controlled trial enrolled adults with cognitive impairment associated with schizophrenia (CIAS).
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It assessed the safety, efficacy and tolerability of the asset in these subjects.
According to the findings, luvadaxistat did not offer improvement in cognitive impairment in schizophrenia patients in the ERUDITE study, a second Phase II trial of the asset.
The study’s failure to meet cognitive endpoints is said to contrast with the earlier INTERACT study’s positive results, the company noted.
The variability in cognitive measures and potential baseline characteristic imbalances across treatment arms have been cited as contributing factors to the latest outcomes.
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By GlobalDataA selective inhibitor targeting d-amino acid oxidase (DAAO), luvadaxistat is designed to modulate NMDA receptor function in the brain, which is implicated in the cognitive deficits observed in schizophrenia.
Neurocrine acquired the rights to develop and commercialise luvadaxistat from Takeda Pharmaceutical.
Neurocrine Biosciences chief medical officer Eiry Roberts said: “While it’s disappointing that luvadaxistat did not meet the primary endpoint in this study, we understand the challenges and hurdles that exist in identifying potential medicines for the treatment of cognitive impairment in schizophrenia.
“We, therefore, plan to halt further development of luvadaxistat at this time and instead will focus our efforts and resources on the advancement into Phase III clinical development of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder.
“We are excited by the opportunity that lies ahead of us to bring forward potential medicines for patients in these important areas of unmet need in neuropsychiatry.”
In August, the company reported positive top-line results from its Phase II clinical study of NBI-1117568, an investigational oral treatment for schizophrenia.
