Vyne Therapeutics Shifts Focus After FDA Hold on Psoriasis Trial

Vyne Therapeutics, a biotech company developing novel treatments for immune-mediated diseases, has announced significant changes to its clinical development program following a partial FDA hold on its phase 1b plaque psoriasis trial for VYN202, an oral BET inhibitor.

FDA Hold and Trial Modifications

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Vyne's phase 1b study of VYN202 in April after reports of testicular toxicity in dogs from a separate, nonclinical test. Subsequently, the FDA has partially lifted the hold, allowing the continuation of the trial for female patients at lower doses of 0.25 mg and 0.5 mg. However, the 1 mg dose remains suspended due to safety concerns.

Vyne has decided to discontinue further enrollment in the phase 1b psoriasis study, citing the need for additional toxicology studies in male patients and the desire to reallocate resources. This decision is expected to extend the company's cash runway into the fourth quarter of 2026.

Promising Early Results and Future Plans

Despite the setback, Vyne remains optimistic about VYN202's potential. The company released unblinded data from six patients who received the drug before the hold was implemented. These early results showed encouraging signs of efficacy:

• All treated patients experienced improvements in psoriasis symptoms
• A 27% reduction in psoriasis area and severity was observed after one week
• One patient achieved a 90% reduction at Week 8
• Reductions in serum cytokine levels associated with plaque psoriasis were noted in subjects treated for more than a week

Based on these results and preclinical data, Vyne plans to continue developing VYN202 for serious, immune-mediated diseases with limited treatment options. The company will outline its strategy for VYN202 after receiving topline results from an ongoing phase 2 trial of repibresib gel, its lead pan-bromodomain BET inhibitor for non-segmental vitiligo.

Market Response and Future Outlook

The announcement has had an immediate impact on Vyne's stock, which dropped 13% following the news, trading at $1.54 per share as of 10:30 a.m. ET on the day of the announcement.

As Vyne navigates these challenges, the pharmaceutical industry will be watching closely to see how the company adapts its development strategy and whether it can successfully leverage the promising early data from VYN202 to advance treatments for immune-mediated diseases.