Neurocrine says Phase 3 KINECT-DCP study of valbenazine did not meet endpoints

Neurocrine (NBIX) Biosciences announced that its Phase 3 KINECT-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in pediatric and adult participants who have dyskinetic cerebral palsy did not meet primary or key secondary endpoints. The primary objective of the study was to assess improvement in chorea, a type of involuntary movement, in individuals with DCP. “These results are disappointing, as there are no approved treatments for people living with dyskinetic cerebral palsy,” said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. “We are deeply grateful to the patients and their families, as well as the investigators and site staff, whose commitment, dedication, and participation made this clinical trial possible.” The study – the largest double-blind placebo-controlled clinical trial ever completed in DCP – evaluated the efficacy of 14 weeks of treatment with valbenazine compared with placebo in pediatric and adult participants who have dyskinesia due to cerebral palsy with choreiform movements. Adverse events were generally consistent with the established safety profile for valbenazine. Neurocrine will report the full study results at an upcoming scientific meeting.