VYNE Therapeutics is making strides in its clinical programs, focusing on novel therapies for immune-mediated conditions. The company recently announced the completion of enrollment in the Phase 2b trial for VYN201 gel, also known as repibresib, aimed at treating nonsegmental vitiligo, and the initiation of a Phase 1b trial for VYN202, an oral treatment for moderate-to-severe plaque psoriasis. These developments highlight VYNE's commitment to addressing unmet needs in chronic inflammatory and autoimmune diseases.
VYN201: Phase 2b Trial Completion for Nonsegmental Vitiligo
VYNE Therapeutics announced on January 6, 2025, the completion of enrollment in its Phase 2b trial evaluating VYN201 gel for the treatment of nonsegmental vitiligo. The randomized, double-blind, vehicle-controlled trial (NCT06493578) is designed to assess the efficacy, safety, and pharmacokinetics of once-daily repibresib gel in three dose cohorts (1%, 2%, and 3% concentrations) compared to a vehicle. Approximately 180 subjects with active or stable nonsegmental vitiligo were enrolled, with equal randomization across the active drug cohorts or vehicle (~45 subjects in each arm).
The primary efficacy endpoint of the trial is the proportion of subjects achieving an improvement in Facial Vitiligo Area Scoring Index of at least 50% from baseline (F-VASI50) at week 24 compared to vehicle. Secondary endpoints include F-VASI and Total VASI (T-VASI) at weeks 24 and 52. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.
David Domzalski, President and Chief Executive Officer of VYNE, stated, "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 2b trial in the middle of this year."
VYN202: Phase 1b Trial Initiation for Plaque Psoriasis
On February 19, 2025, VYNE Therapeutics announced the dosing of the first subject in a Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor being developed for immune-mediated diseases.
The Phase 1b trial is a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of once-daily VYN202 in three dosing cohorts (0.25 mg, 0.5 mg, 1 mg doses) compared to placebo for 12 weeks in subjects with moderate-to-severe plaque psoriasis. Exploratory efficacy of VYN202 will also be evaluated, including measures of PASI, Static Physician Global Assessment (sPGA), scalp disease, quality of life, and biomarker analyses. Approximately 20 subjects will be randomized equally (1:1:1:1 ratio) across the active drug cohorts or placebo in each arm. Top-line data from the 12-week trial are expected by year-end 2025.
Iain Stuart, PhD, Chief Scientific Officer of VYNE, noted that previous Phase 1a trials showed VYN202 had a favorable safety profile and potential to inhibit the production of multiple inflammatory biomarkers. "We look forward to reporting results from this robust Phase 1b trial by the end of this year," Stuart added.
About Vitiligo and Plaque Psoriasis
Vitiligo is a chronic autoimmune depigmenting disorder of the skin, characterized by the loss of pigment-producing cells known as melanocytes. It affects approximately 0.5-2.0% of the world population. Nonsegmental vitiligo is the most common type.
Plaque psoriasis is a chronic immune-mediated disease resulting in the overproduction of skin cells, causing inflamed, scaly plaques that may be itchy or painful. It is estimated that eight million Americans and more than 125 million people worldwide live with the disease.
About Repibresib and VYN202
Repibresib (VYN201) is a pan-bromodomain BET inhibitor designed to be locally administered as a "soft" drug to address diseases involving multiple, diverse inflammatory cell signaling pathways while providing low systemic exposure. VYN202 is an innovative, oral small molecule BET inhibitor with potential class-leading selectivity and potency for BD2 vs. BD1.
VYNE Therapeutics' Focus
VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE's unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early-generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.
