US-based pharmaceutical company VYNE Therapeutics has completed enrolment in the randomised Phase IIb clinical trial of VYN201 gel, known as repibresib, for treating non-segmental vitiligo.
The double-blind, vehicle-controlled study is assessing the safety, pharmacokinetics and efficacy of once-daily gel application in three dose cohorts in concentrations of 1%, 2% and 3% compared to a vehicle.
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It involves participants with active or stable non-segmental vitiligo who have been equally randomised across the active drug cohorts or vehicles, with around 45 participants in each arm.
The trial’s primary efficacy endpoint is the proportion of participants achieving at least a 50% improvement from the baseline in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle.
Following the initial 24-week treatment period, participants in the active drug cohorts can continue treatment with their respective doses for an extension period of 28 weeks.
Repibresib is a pan-bromodomain and extraterminal inhibitor designed for local administration as a ‘soft’ drug, aiming to target diseases that involve multiple inflammatory cell signalling pathways while minimising systemic exposure.
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By GlobalDataVYNE Therapeutics CEO and president David Domzalski said: “We are pleased to have recently completed enrolment in our Phase IIb trial evaluating VYN201 for the treatment of vitiligo, which marks an important milestone for the programme and reflects the continued strong execution of our clinical team.
“We believe VYN201 gel has the potential to become a differentiated therapy for patients with vitiligo, and we look forward to reporting top-line data from this Phase IIb trial in the middle of this year.”
VYNE expects to report top-line outcomes from the 24-week vehicle-controlled treatment period later this year.
Last year, the company received clearance from the US Food and Drug Administration for its investigational new drug application for VYN202, enabling the start of a Phase Ia clinical trial.
