VYNE Therapeutics Faces Clinical Hold on VYN202 Program Following Toxicity Findings

VYNE Therapeutics Inc. (Nasdaq: VYNE) has announced a temporary halt in its Phase 1b clinical trial of VYN202, a novel treatment for moderate-to-severe plaque psoriasis, following a clinical hold imposed by the U.S. Food and Drug Administration (FDA). The FDA’s decision came after the company observed testicular toxicity in dogs during a non-clinical toxicology study of VYN202.

As a result, VYNE has suspended all screening, patient enrollment, and dosing in the ongoing Phase 1b trial. The company, however, emphasized that no serious adverse events have been reported in the patients already enrolled in the study.

FDA Clinical Hold: A Step Toward Resolution

VYNE has expressed its commitment to working closely with the FDA to resolve the clinical hold swiftly. "While we are disappointed by this unexpected development, the safety and well-being of patients in our studies is our top priority,” said David Domzalski, President and CEO of VYNE Therapeutics. "We intend to work closely with the FDA to address the clinical hold as expeditiously as possible and we plan to provide additional updates pending continued engagement with the FDA.”

Despite the setback with VYN202, the company emphasized that the clinical hold does not affect its ongoing Phase 2b trial of repibresib gel, an entirely different compound designed for the treatment of nonsegmental vitiligo. VYNE is still on track to release top-line results from the 24-week, double-blind, vehicle-controlled portion of the Phase 2b study in mid-2025.

About VYNE Therapeutics

VYNE Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing differentiated therapies aimed at treating chronic inflammatory and immune-mediated conditions with significant unmet medical needs. The company's proprietary BET inhibitors, part of its InhiBET™ platform, are designed to overcome limitations seen in early-generation BET inhibitors, offering enhanced selectivity and alternative administration routes.

Investors and stakeholders can follow VYNE’s progress and updates through its website and official filings, as the company continues to navigate its clinical trials and regulatory challenges.