VYNE Therapeutics (VYNE) Reports Phase 2 Study of VY2021-01 Did Not Meet Primary Endpoint

August 10, 2022 8:33 AM EDT

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VYNE Therapeutics Inc. (Nasdaq: VYNE) today announced results from the Phase 2a segment of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (“AD”).

Study VY2021-01 did not meet its primary endpoint based on the absolute and percent change relative to baseline in the Atopic Dermatitis Severity Index (“ADSI”). The Phase 2a study of FMX114 enrolled 21 patients and was designed to evaluate four weeks of FMX114 treatment in patients with mild-to-moderate AD compared to vehicle control. The enrollment criteria specified that subjects must have two comparable target AD lesions for treatment upon entry. Target lesions were randomized and treated twice daily with either FMX114 or vehicle gel.

Efficacy data for the Phase 2a trial was measured based on the absolute and percent change relative to baseline in the ADSI scoring assessment1 at week 4.

  • Mean ADSI scores for FMX114 and vehicle treated lesions were 6.6 and 6.9, respectively, at baseline
  • Mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle treated lesions at week 4 (p=0.228, OC, ITT)

“We’re obviously very disappointed by the outcome of this trial for FMX114,” said David Domzalski, Chief Executive Officer of VYNE. “We will continue to thoroughly review the full data set and complete our analysis. In addition, as a result of this outcome, our management team and our board of directors will evaluate the Company’s pipeline and prioritization of activities.”

The Company expects to report cash and cash equivalents of approximately $43 million as of June 30, 2022. Additionally, the Company is entitled to receive a $5.0 million payment in January 2023 in connection with the sale of the MST franchise.

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