VYNE Therapeutics Advances VYN202 with Phase 1b Trial in Moderate to Severe Plaque Psoriasis

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VYNE Therapeutics Inc. has announced the initiation of a phase 1b clinical trial to evaluate the safety and preliminary efficacy of VYN202, an oral, BD2-selective bromodomain and extra-terminal domain (BET) inhibitor, in patients with moderate to severe plaque psoriasis.¹

The decision to advance VYN202 into phase 1b is backed by robust data from its phase 1a trial, which assessed its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers.^2-3

The study demonstrated favorable safety and tolerability across multiple dose levels (0.5 mg every other day, 0.5 mg daily, and 1 mg daily) with no serious adverse events or laboratory abnormalities. Researchers reported no concerning drug interactions in participants who also received methotrexate.

David Domzalski, president and CEO of VYNE, emphasized the significance of VYN202's advancement: "The initiation of the phase 1b trial in subjects with moderate to severe plaque psoriasis represents a major step forward in advancing our novel and highly selective oral BET inhibitor, VYN202."¹

The phase 1b study is a randomized, double-blind, placebo-controlled trial evaluating VYN202 over a 12-week period. Approximately 80 participants with moderate to severe plaque psoriasis will be enrolled and randomized into 4 groups: 3 receiving active treatment (0.25 mg, 0.5 mg, or 1 mg doses) and 1 receiving placebo.

The trial’s primary endpoint is safety and tolerability, while secondary objectives include pharmacokinetic analysis and preliminary efficacy assessments, such as Psoriasis Area and Severity Index improvement, Static Physician Global Assessment, scalp disease severity, quality of life measures, and biomarker analyses

Following the treatment period, participants will be monitored for an additional 4 weeks for safety follow-up.

While VYN202 is currently being evaluated in psoriasis, its mechanism of action suggests broader applications. Inflammatory pathways regulated by BET proteins are involved in conditions such as rheumatoid arthritis and inflammatory bowel disease.³

Chief Scientific Officer Iain Stuart, PhD, highlighted the drug’s potential.

"Our phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial showed that VYN202 had a favorable safety profile and also demonstrated VYN202’s potential to inhibit the production of multiple inflammatory biomarkers related to Th17, TNF and Th1/myeloid dysregulated activity," he said in a news release.¹

Top-line data from the phase 1b trial are expected by the end of 2025. If the results confirm a favorable safety profile and demonstrate efficacy signals, VYN202 could progress to larger phase 2 trials, positioning it as a potential new option for systemic psoriasis treatment.

Reference

1. VYNE Therapeutics initiates phase 1b trial of VYN202, a novel BD2-selective oral BET inhibitor, in plaque psoriasis. News release. Globe Newswire. February 19, 2025. Accessed February 19, 2025. https://www.globenewswire.com/news-release/2025/02/19/3028700/0/en/VYNE-Therapeutics-Initiates-Phase-1b-Trial-of-VYN202-a-Novel-BD2-Selective-Oral-BET-Inhibitor-in-Plaque-Psoriasis.html
2. VYNE Therapeutics reports positive top-line phase 1a MAD data for VYN202, its novel BD2-selective BET inhibitor. News release. BioSpace. September 12, 2024. Accessed February 19, 2025. https://www.biospace.com/press-releases/vyne-therapeutics-announces-positive-phase-1a-sad-data-for-vyn202-a-novel-bd2-selective-bet-inhibitor
3. VYNE Therapeutics announces positive phase 1a SAD data for VYN202, a novel BD2-Selective BET inhibitor. News release. BioSpace. December 23, 2024. Accessed February 19, 2025. https://www.biospace.com/press-releases/vyne-therapeutics-announces-positive-phase-1a-sad-data-for-vyn202-a-novel-bd2-selective-bet-inhibitor