VYNE Therapeutics Finishes Phase 2b Trial Enrollment for VYN201 in Nonsegmental Vitiligo Treatment

VYNE Therapeutics Inc., a biopharmaceutical company listed on Nasdaq, has announced the completion of enrollment for its Phase 2b clinical trial aimed at evaluating the efficacy of the VYN201 gel in treating nonsegmental vitiligo. The company anticipates sharing the top-line results from this 24-week, double-blind study by mid-2025. This trial is a critical step forward in the company's efforts to develop therapies for chronic inflammatory and immune-mediated conditions that are currently underserved.

David Domzalski, the CEO of VYNE, expressed enthusiasm about reaching this milestone, emphasizing the potential of VYN201 gel as a novel treatment option for individuals affected by vitiligo. The anticipation is high for the revealing of the trial's findings, which could significantly influence the treatment landscape for this skin disorder.

The United States Adopted Names (USAN) Council has assigned the chemical entity in VYN201 the non-proprietary name "repibresib." This name will be used extensively in future public communications and documentation as the company progresses with the clinical development of the product.

The Phase 2b trial is structured as a randomized, double-blind, and vehicle-controlled study. It investigates the safety, efficacy, and pharmacokinetics of once-daily application of repibresib gel in three different dosages—1%, 2%, and 3%—compared with a placebo. Participants, who have varying stages of nonsegmental vitiligo, are randomly assigned in equal numbers to one of the active treatment cohorts or a vehicle group. Each group consists of approximately 45 subjects. Those receiving the active treatment will have the opportunity to continue their respective doses for an additional 28 weeks if they choose. Participants initially assigned to the vehicle group will be re-randomized into one of the active treatment groups for a similar extended period.

The primary goal of the trial is to measure the proportion of participants achieving at least a 50% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI50) after 24 weeks of treatment, in comparison to the vehicle group. Secondary measures include assessments of F-VASI and Total VASI (T-VASI) at both 24 and 52 weeks.

Vitiligo is a chronic autoimmune condition that leads to skin depigmentation due to the loss of melanocytes, the cells responsible for pigment production. It affects between 0.5% to 2.0% of the global population, with nonsegmental vitiligo being the most prevalent form. Currently, there is only one FDA-approved treatment available for this condition.

Repibresib, a pan-bromodomain BET inhibitor integrated into a topical gel, is designed to target diseases involving multiple inflammatory pathways while minimizing systemic exposure. It has shown potential in reducing pro-inflammatory biomarkers and improving disease severity in several preclinical models. By inhibiting BET proteins, which are crucial in gene transcription and immune cell activation, repibresib could offer a new line of treatment for various inflammatory and fibrotic diseases.

VYNE is committed to advancing its pipeline of innovative therapies through its proprietary InhiBET™ platform, which aims to enhance the delivery and selectivity of BET inhibitors. This approach seeks to overcome the limitations of earlier generations of BET inhibitors, offering hope for more effective treatments in the future.