First patient dosed in phase 2b trial of VYN201 for treatment of nonsegmental vitiligo

Key takeaways:

• In the phase 2b trial, 160 subjects will be randomly assigned to receive one of three concentrations of VYN201 or placebo.
• Results from the 24-week period of the study will be released in 2025.

The first subject has been dosed in a phase 2b trial evaluating VYN201 for the treatment of active or stable nonsegmental vitiligo.

As Healio previously reported, VYN201 is a pan-bromodomain BET inhibitor designed to be locally administered to address inflammatory cell signaling pathways. Following positive results from VYNE Therapeutics’ phase 1b trial of VYN201, the company has now begun its phase 2b trial.

“In our prior phase 1b trial, VYN201 demonstrated a significant clinical response with a rapid onset of action and a favorable safety and tolerability profile, including low systemic exposure,” David Domzalski, president and CEO of VYNE, said in the release. “We believe that VYN201 has the potential to become a valuable and differentiated therapy for patients with vitiligo.”

According to the release, the randomized, double-blind, vehicle-controlled trial will evaluate the efficacy and safety of three difference concentrations of once-daily VYN201 topical gel: 1%, 2% and 3%. These results will be compared with placebo over the span of 24 weeks.

Approximately 160 subjects will be included in the study and randomly assigned 1:1:1:1 among treatment cohorts. After 24 weeks of treatment, the subjects in the VYN201 treatment cohorts will continue their initial dosages, whereas those previously taking placebo will be randomly assigned to one of the three VYN201 concentrations for an additional 28 weeks.

The primary endpoint of the trial is for a proportion of subjects to achieve at least a 50% improvement in their Facial Vitiligo Area Scoring Index scores from baseline by week 24.

“We look forward to reporting top-line data from the 24-week treatment period in mid-2025,” Domzalski said.