Vyne Therapeutics’ lead asset has failed to improve the severity of mild-to-moderate atopic dermatitis, uprooting the biotech’s plans and sending the stock plummeting.
The data comes from a phase 2a segment of a phase 1b/2a clinical trial assessing FMX114, a topical combo gel made of Pfizer’s JAK inhibitor Xeljanz and Novartis’ S1P modulator Gilenya. The gel didn’t hit its main efficacy target, which was to improve symptoms and severity of atopic dermatitis, or eczema.
Vyne’s shares tumbled almost 30% Wednesday morning to 28 cents apiece compared to a prior close of 40 cents after the results were announced.
As a result, Vyne will be reevaluating its pipeline and prioritization of activities, according to CEO David Domzalski.
The study enrolled 21 patients and evaluated four weeks of FMX114 treatment in patients with mild-to-moderate AD compared to vehicle control gel. Each patient had two comparable target AD lesions, with FMX114 gel applied to one lesion and vehicle gel to the other twice daily.
For FMX114 treated lesions, mean severity decreased by 61% at four weeks, compared to 51% for vehicle treated lesions, a result that is not statistically significant.
“We’re obviously very disappointed by the outcome of this trial for FMX114,” said Domzalski. Vine will continue to analyze the full data set, he added.
Earlier this year, Vyne pushed ahead after phase 1b data suggested the gel may have the desired mix of local efficacy and limited systemic exposure.
The New Jersey biotech, which focuses on immuno-inflammatory conditions, has two other candidates in its pipeline, both of which are in preclinical development and sourced from a library of bromodomain and extra-terminal domain inhibitors licensed from In4Derm.
The biotech reported cash and cash equivalents of $43 million as of June 30.