VYNE begins trial for new psoriasis treatment

Published 19/02/2025, 14:07
Updated 19/02/2025, 14:08
VYNE begins trial for new psoriasis treatment

BRIDGEWATER, N.J. – VYNE Therapeutics Inc. (NASDAQ:VYNE), a clinical-stage biopharmaceutical company with a market capitalization of $36.2 million, has announced the initiation of a Phase 1b trial for their drug candidate VYN202, targeting moderate-to-severe plaque psoriasis. The first subject has been dosed, marking a significant step in the development of this potential new treatment. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, with analysts setting price targets between $5 and $8.

VYN202 is an oral small molecule inhibitor that selectively targets the bromodomain and extra-terminal domain (BET) proteins, which are implicated in inflammatory and immune-mediated diseases. The trial will primarily assess the safety of the drug given once daily over 12 weeks and will also evaluate its pharmacokinetics and preliminary efficacy. Efficacy will be measured by improvements in the psoriasis area and severity index (PASI) scores from baseline. The company maintains a strong liquidity position with a current ratio of 5.81, indicating substantial resources to support its clinical development programs.

The randomized, double-blind, placebo-controlled study will involve around 80 subjects, divided into four groups, including three different dosages of VYN202 and a placebo group. Following the treatment period, there will be an additional 4-week safety follow-up.

David Domzalski, President and CEO of VYNE, expressed optimism about the potential of VYN202 to provide insights into the treatment of chronic immune-mediated diseases, given psoriasis’s shared biological pathways with other inflammatory conditions. Iain Stuart, PhD, and Chief Scientific Officer, highlighted the favorable safety profile observed in previous Phase 1a trials and the drug’s ability to inhibit the production of multiple inflammatory biomarkers.

Plaque psoriasis affects millions worldwide and is characterized by inflamed, scaly plaques on the skin. VYNE’s BET inhibitors aim to offer a non-biologic treatment option that could manage the chronic aspects of immuno-inflammatory diseases.

Top-line data from the trial are anticipated by the end of 2025. The company’s progress in this trial is part of their broader effort to address unmet needs in chronic inflammatory and immune-mediated conditions. The information in this article is based on a press release statement from VYNE Therapeutics Inc.

In other recent news, VYNE Therapeutics has completed enrollment in a Phase 2b trial for its vitiligo treatment, VYN201. This trial aims to assess the safety and efficacy of a topical gel in three concentrations over a 24-week period, involving approximately 160 participants. The primary objective is to determine the percentage of participants achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index at the 24-week mark. H.C. Wainwright has maintained its Buy rating for VYNE Therapeutics, with a price target of $5.75, citing the clinical progress of VYN201. The firm expresses optimism based on positive safety and efficacy results from a previous Phase 1b trial. The current trial also includes an extension phase for those who received the active gel. Top-line results from this trial are anticipated in mid-2025. H.C. Wainwright’s continued support reflects confidence in the treatment’s potential and its mechanism of action.

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