Neurocrine Biosciences has reported that its Phase III trial assessing the selective vesicular monoamine transporter 2 (VMAT2) inhibitor, valbenazine, for dyskinetic cerebral palsy in paediatric and adult populations, failed to achieve the endpoints.
The principal aim of the KINECT-DCP study was to determine whether valbenazine could improve chorea, an involuntary movement disorder, in those with DCP.
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Neurocrine Biosciences chief medical officer Sanjay Keswani said: “These results are disappointing, as there are no approved treatments for people living with dyskinetic cerebral palsy.
“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 double-blind, randomised, placebo-controlled trial was designed to evaluate the safety, tolerability, and efficacy of the therapy for treating dyskinesia in those with choreiform movements due to CP.
Patients who are six to 70 years old were randomised and given either the therapy or a placebo for a 14-week period during the double-blind phase.
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By GlobalDataAfter this period, participants could enter an open-label extension, in which all were given valbenazine.
Neurocrine Biosciences noted that it will present the full trial outcomes at an upcoming scientific meeting.
CP is a nonprogressive neurodevelopmental disorder that impacts posture and movement and begins in early childhood.
In 2017, the company gained approval from the US Food and Drug Administration for valbenazine as the first drug developed for treating tardive dyskinesia.
In 2023, the therapy secured the US regulator approval to treat chorea associated with Huntington’s disease.
Neurocrine noted that it is developing two next-generation VMAT2 inhibitors, with NBI-1065890 set to enter Phase II development for tardive dyskinesia next year.
