Neuroscience-focused biopharmaceutical company Neurocrine Biosciences Inc (Nasdaq: NBIX) disclosed on Monday that its Phase 3 KINECT-DCP study evaluating the efficacy, safety, and tolerability of valbenazine in paediatric and adult participants with dyskinetic cerebral palsy (DCP) did not meet primary or key secondary endpoints.
The study's primary objective was to evaluate improvement in chorea, a type of involuntary movement, in individuals with DCP.
Sanjay Keswani, M.D., chief medical officer at Neurocrine Biosciences, said: "These results are disappointing, as there are no approved treatments for people living with dyskinetic cerebral palsy."
In the study -- the largest double-blind, placebo-controlled clinical trial ever completed in DCP -- investigators assessed the efficacy of 14 weeks of treatment with valbenazine compared with placebo in paediatric 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, the company said.
Neurocrine Biosciences will report the full study results at an upcoming scientific meeting.
Faron launches BLAZE trial with Institute of Cancer Research to address immunotherapy resistance
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Ipsen licenses Simcere Zaiming antibody-drug conjugate for global development
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Ipsen closes Phase II FALKON trial after missing primary endpoint in FOP
Curasight reports first patient dosed in Phase 1 uTREAT trial in brain cancer
Clywedog Therapeutics activates all clinical centres and patient dosing in balomenib Phase 1b study
PRISM BioLab partners with Talus Bioscience to address TF and PPI targets