VYNE Therapeutics Announces Results From Phase 2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis
VYNE Therapeutics Inc. recently 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 4 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 assessment 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-million payment in January 2023 in connection with the sale of the MST franchise.
The Phase 2a segment of the study is a randomized, double-blinded trial, designed to compare the safety and efficacy of FMX114 gel with vehicle gel. The Phase 2a segment was designed to enroll up to 25 subjects, with each subject serving as their own control. As in the Phase 1b study, the enrollment criteria specifies that subjects must have two comparable target AD lesions for treatment upon entry. Participants had FMX114 gel applied to one of these lesions and vehicle gel to the other, twice daily for four weeks to evaluate safety, pharmacokinetics and efficacy. Following this phase, subjects were eligible to continue into a two-week open-label treatment phase with active drug applied to both lesions. The study was conducted at sites in Australia and in the US.
VYNE’s mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary pipeline includes access to a library of bromodomain & extra-terminal (BET) domain inhibitors licensed from In4Derm Limited. The BET inhibitor platform includes lead programs VYN201 (pan-BETi) and VYN202 (selective-BETi) and access to a library of (BET) domain inhibitors for the potential treatment of immuno-inflammatory conditions. For more information, visit www.vynetherapeutics.com.
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