practicaldermatology.com
VYNE Therapeutics Inc. has finalized enrollment for its Phase 2b trial of VYN201, a once-daily topical gel for nonsegmental vitiligo, with initial data from the 24-week double-blind portion anticipated in mid-2025, according to a news release from the manufacturer.
The randomized, double-blind, vehicle-controlled trial (NCT06493578) includes 180 participants divided into three active dose groups (1%, 2%, 3%) and one vehicle group, and all were randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle (~45 subjects in each arm). Following the 24-week treatment period, subjects who have been randomized in the 1%, 2% and 3% cohorts will have the option to continue treatment with their respective dose concentrations for an additional 28-week extension, according to the press release. Participants who have been randomized in the vehicle group during the initial 24-week treatment period will be equally re-randomized into one of the three active dose cohorts for an additional 28 weeks. The primary study endpoint is the percentage of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle. Secondary endpoints include additional F-VASI and Total VASI (T-VASI) assessments at weeks 24 and 52.
“We are pleased to have recently completed enrollment in our Phase 2b trial evaluating VYN201 for the treatment of vitiligo, which marks an important milestone for the program and reflects the continued strong execution of our clinical team,” said David Domzalski, President and CEO of VYNE, in a press release. "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."
The US Adopted Names Council has also approved "repibresib" as the non-proprietary name for VYN201.
Source: VYNE press release. Jan 6, 2025.