Month: June 2024

BRIDGEWATER, N.J., June 13, 2024 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first healthy volunteers have been dosed in the Phase 1a trial of VYN202. VYN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases. Top-line data are expected in the second half of 2024.

“We are pleased to announce the initiation of the first-in-human clinical trial of VYN202, a highly selective and potent orally administered BET inhibitor. In preclinical testing, VYN202 achieved consistent improvements in disease severity across a variety of inflammatory and fibrotic models as well as reductions in pro-inflammatory and disease-related biomarkers,” said David Domzalski, President and CEO of VYNE. “We believe VYN202 has significant potential as a treatment option for a broad range of immune-mediated diseases, and we look forward to reporting top-line data from the Phase 1a trial in the second half of this year.”

The Phase 1a trial is a first-in-human double-blind, placebo-controlled study in healthy volunteers and consists of single ascending dose (SAD) and multiple ascending dose (MAD) components. The trial is currently expected to enroll approximately 64 healthy adult subjects into five SAD and three MAD cohorts to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.

“Early generation BET inhibitors show similar affinity to both BD1 and BD2 bromodomains of BET proteins that has been implicated in both gastrointestinal and hematologic dose limiting toxicities,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE. “We believe VYN202’s high potency and selectivity towards the BD2 bromodomain of BET proteins may result in an improved benefit-risk profile when treating immuno-inflammatory diseases. Following highly encouraging preclinical data, we are eager to evaluate the clinical safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 to further inform our future clinical development plans.”

BRIDGEWATER, N.J., June 05, 2024 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first subject has been dosed in a Phase 2b trial evaluating VYN201 in subjects with either active or stable nonsegmental vitiligo. VYN201 is a novel pan-bromodomain and extra-terminal domain (BET) inhibitor designed for local administration. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.

The randomized, double-blind, vehicle-controlled trial will evaluate the safety and efficacy of once-daily VYN201 topical gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. A total of approximately 160 subjects will be randomized at a 1:1:1:1 ratio. Following the 24-week treatment period, subjects in the active treatment arms will continue for an additional 28 weeks, and subjects in the vehicle group will be equally re-randomized to receive VYN201 1%, 2% or 3% gel for an additional 28 weeks. 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, with additional secondary endpoints of F-VASI and Total VASI (T-VASI) at weeks 24 and 52.

“Dosing the first subject in the Phase 2b trial for vitiligo is an important milestone for the VYN201 program and our Company,” said David Domzalski, President and CEO of VYNE. “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. We believe that VYN201 has the potential to become a valuable and differentiated therapy for patients with vitiligo. We look forward to reporting top-line data from the 24-week treatment period in mid-2025.”