FDA partially lifts clinical hold on VYNE’s VYN202 psoriasis trial

BRIDGEWATER, N.J. - VYNE Therapeutics Inc. (NASDAQ:VYNE), a clinical-stage biotech company with a current market capitalization of $29.5 million, announced Wednesday that the U.S. Food and Drug Administration has partially lifted a clinical hold on its Phase 1b trial of VYN202 for moderate-to-severe plaque psoriasis, allowing the company to resume testing in female patients at the 0.25 mg and 0.5 mg dose levels. The stock has shown significant momentum, gaining 29.2% in the past week, according to InvestingPro data.

The FDA had placed the clinical hold in April following observations of testicular toxicity in dogs during a non-clinical toxicology study. The 1 mg dose was not included in the revised protocol due to its lower toxicological safety margin compared to the lower doses.

VYNE has decided to discontinue enrollment in the Phase 1b psoriasis study, which the company said would extend its expected cash runway into the fourth quarter of 2026. This decision comes as InvestingPro analysis shows the company holds more cash than debt on its balance sheet, with a healthy current ratio of 4.47, though it’s currently burning through cash at a notable rate. The company unblinded data from the seven subjects who had already been enrolled in the trial.

Preliminary results from these patients showed no treatment-emergent serious adverse events or discontinuations due to clinical adverse events. The company reported that all subjects treated with VYN202 showed improvements in disease symptoms, with reductions in PASI scores ranging from approximately 27% after one week to 90% at week eight.

The company also noted improvements in serum cytokine levels involved in plaque psoriasis pathogenesis in subjects treated with VYN202 for more than one week, with reductions ranging from 17% to 83%.

One subject with psoriatic arthritis who received VYN202 0.5 mg reported a four-point improvement in joint pain by week two, corresponding with a 48% reduction in serum c-reactive protein level.

VYNE expects to provide further updates on its plans for the VYN202 program after releasing top-line results from its ongoing Phase 2b study of repibresib gel (formerly VYN201) for non-segmental vitiligo.

VYN202 is an oral BD2-selective bromodomain and extra-terminal domain (BET) inhibitor being developed for immune-mediated diseases.

The information in this article is based on a company press release statement.

In other recent news, VYNE Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Phase 1b study of VYN202, a drug candidate for moderate-to-severe plaque psoriasis. This decision followed the discovery of testicular toxicity in dogs during a non-clinical toxicology study. As a result, VYNE has paused all screening, enrollment, and dosing of patients in the trial. Despite this setback, no serious adverse events have been reported among the human subjects enrolled in the study so far. The clinical hold does not affect VYNE’s ongoing Phase 2b trial of repibresib gel for nonsegmental vitiligo, with top-line results expected by mid-year.

H.C. Wainwright has maintained a Buy rating on VYNE’s stock but lowered the price target from $5.75 to $4.50, reflecting concerns about potential hurdles such as inconclusive clinical trials and funding challenges. VYNE’s leadership remains committed to resolving the clinical hold swiftly and is in continued discussions with the FDA. The company has emphasized its focus on patient safety and its dedication to advancing its product pipeline. Investors are keeping a close eye on VYNE’s progress as it navigates these challenges.

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