VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis

VYNE Therapeutics Inc. recently announced the completion of enrollment in the Phase 2a study of FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD).

FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation in AD. In April 2022, VYNE reported positive efficacy data from the Phase 1b segment of the trial, demonstrating that treatment with FMX114 resulted in a statistically significant reduction in both absolute and percent change in mean Atopic Dermatitis Severity Index (ADSI) score compared to vehicle. FMX114 treatment also substantially reduced pruritus (itch) as measured on the worst pruritus Numerical Rating Scale (NRS).

The Phase 2a segment of the FMX 114 study is designed to evaluate 4 weeks of FMX114 treatment in patients with AD compared to vehicle control. Due to the impact of COVID-19 on enrollment and other operations related to the original trial sites in Australia, the company activated additional clinical trial sites in the US to support patient enrollment and expedite completion of the study. With enrollment now completed, the company expects to report top-line efficacy results in approximately 6 to 8 weeks.

“We have been encouraged by the early efficacy results from the Phase 1b segment of the FMX114 trial showing that, based on ADSI scoring, two weeks of FMX114 treatment demonstrated a statistically significant improvement in the signs and symptoms of AD as well as acceptable safety and pharmacokinetics,” said David Domzalski, Chief Executive Officer of VYNE Therapeutics. “We look forward to reporting the results of the Phase 2a segment of the study in approximately 6 to 8 weeks.”

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 will have FMX114 gel applied to one of these lesions and vehicle gel to the other. Treatment will be applied twice daily for four weeks to evaluate safety, pharmacokinetics and efficacy. After completion of this phase, these subjects may continue into a 2-week open-label treatment phase and will be able to apply the active drug to both lesions. The study is being conducted at sites in Australia and in the US.

FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is designed to address both the source and cause of inflammation in AD through a combination of tofacitinib (a Janus kinase inhibitor) that acts with cells to reduce inflammation by inhibiting cytokine release from inflammatory cells) and fingolimod (a Sphingosine 1-phosphate receptor modulator) that acts outside of cells to reduce inflammation by inhibiting migration of inflammatory cells. In addition, fingolimod may also directly support skin barrier recovery because it is known to upregulate filaggrin, a protein that plays an important role in the skin’s barrier function. FMX114 has the potential to be the first topical combination product for the treatment of AD as well as the first topical product in clinical development that utilizes the sphingosine 1-phosphate receptor modulation mode of action.

Atopic dermatitis (AD) is a chronic, severe form of eczema that is characterized by the appearance of dry, red, and itchy skin. AD most commonly affects the cheeks, arms, and legs. Flare-ups often occur and symptoms can worsen leading to more-intense itching and worsening of disease. AD flares are triggered by stress, temperature changes, sweat, various skin irritants, and allergies. AD can have a wide-ranging impact on quality of life and there is a substantial monetary burden from direct and indirect costs to this patient population. While AD occurs most often in childhood, it can develop at any point in a person’s lifetime and affects approximately 30 million people in the US alone. Approximately 22 million of those diagnosed are on treatment, with 19 million registering mild to moderate disease. According to Symphony Health data, there were over 7 million prescriptions written in 2019 alone for the treatment of AD.

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 FMX114 for the potential treatment of mild-to-moderate atopic dermatitis, and 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.