Author: admintay

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.”

BRIDGEWATER, N.J., May 06, 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 the clearance of its Investigational New Drug application (“IND”) by the U.S. Food and Drug Administration for VYN202, an oral BD2-selective BET inhibitor. VYNE plans to initiate a first-in-human Phase 1a single ascending dose/multiple ascending dose (“SAD/MAD”) trial in healthy volunteers this quarter and expects to report top line results from the SAD/MAD trial in the second half of this year.

“VYN202 is a highly selective and potent orally administered BET inhibitor that we believe has significant potential as a treatment option for autoimmune diseases. Clearance of the IND for VYN202 marks a major step forward in this effort,” said David Domzalski, President and CEO of VYNE. “We look forward to initiating the Phase 1a trial in the coming weeks to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.”

The VYN202 Phase 1a trial is a double-blind, placebo-controlled study in healthy volunteers and consists of SAD and MAD components. The study is 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. If the Phase 1a portion of the trial is successfully completed, VYNE plans to initiate Phase 1b trials in subjects with moderate-to-severe plaque psoriasis and moderate-to-severe adult-onset rheumatoid arthritis, with top line results anticipated in the second half of 2025.

BRIDGEWATER, N.J., Jan. 10, 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 new biomarker data from the previously completed Phase 1b trial in patients with nonsegmental vitiligo. The data show that BET inhibitor, VYN201, had a positive effect on multiple disease-associated biomarkers.

Positive clinical data from the Phase 1b trial were announced in October 2023. The trial was a 16-week open-label study assessing the safety, tolerability, pharmacokinetics, and exploratory efficacy of once-daily topical VYN201 in 29 patients with a clinical diagnosis of active nonsegmental vitiligo, in three dose cohorts (0.5%, 1.0% and 2.0% strengths). Enrolled subjects had two, non-facial active vitiligo lesions. One lesion, selected for treatment with VYN201, had skin tissue biopsies taken prior to first application of VYN201 and after 8 weeks of treatment. Biopsies were analyzed to quantify the effect of VYN201 on specific biomarkers related to inflammation associated with vitiligo, melanocyte proliferation, and melanogenesis. Exploratory data from the 1.0% and 2.0% cohorts showed that VYN201 treatment demonstrated biological activity and a positive effect on certain key biomarkers relevant to vitiligo disease severity and progression. The magnitude of biomarker modulation was more pronounced in the 2.0% dose cohort than in the 1.0% dose cohort, indicative of an emerging dose-response.