Pharma Focus Asia

VYNE Therapeutics Launches Phase 2b Clinical Trial for VYN201, a New BET Inhibitor in Vitiligo Research

Thursday, June 06, 2024

VYNE Therapeutics Inc. (Nasdaq: VYNE) is advancing in its clinical research aimed at developing new treatments for conditions involving immune system inflammation. The company has launched a Phase 2b clinical trial for VYN201, an innovative BET inhibitor, intended for patients with nonsegmental vitiligo. This local application gel is being tested in three different strengths (1%, 2%, and 3%) against a placebo over a 24-week period. The study will enroll about 160 participants who will be assigned randomly to one of these groups in a balanced ratio. After the initial treatment phase, those receiving the active treatment will participate in an additional 28-week period, while those on the placebo will be re-randomized to one of the active treatment groups.

The primary outcome of this trial is to determine the effectiveness of VYN201 by evaluating the proportion of participants who experience at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) from the start of the study at week 24, compared to the placebo group. Secondary outcomes will include changes in the Facial Vitiligo Area Scoring Index (F-VASI) and Total Vitiligo Area Scoring Index (T-VASI) at weeks 24 and 52.

VYNE, noted the importance of this trial, pointing out the encouraging results from an earlier Phase 1b trial that showed a significant clinical response, quick onset of effects, and a favorable safety profile with minimal systemic exposure. VYN201 could potentially offer a valuable treatment option for those suffering from vitiligo, with top-line results expected from the 24-week period in mid-2025.

Vitiligo is a persistent skin disorder characterized by the loss of pigment-producing melanocytes, affecting approximately 0.5-2.0% of the global population. Currently, there is only one FDA-approved treatment for this condition.

VYN201 is designed as a pan-bromodomain BET inhibitor for local administration, targeting various inflammatory pathways while minimizing systemic exposure. It has shown effectiveness in treating vitiligo and has consistently reduced biomarkers associated with the disease in preclinical studies using different administration methods.

BET inhibitors are vital in controlling gene transcription through epigenetic mechanisms, affecting inflammatory processes by regulating the activation of B and T cells and the production of pro-inflammatory cytokines. This suggests that BET inhibitors could be useful in treating a range of immuno-inflammatory and fibrotic diseases, as well as disorders associated with abnormal cell growth in the blood.



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