VYNE Therapeutics has concluded subject enrolment in the Phase IIa clinical trial of FMX114 to treat mild-to-moderate atopic dermatitis (AD).

An investigational combination gel formulation of tofacitinib and fingolimod, FMX114 is intended to address the source and cause of AD inflammation. 

It could become the first topical product to treat AD and the first in the clinical development stage that uses the sphingosine 1-phosphate receptor modulation mode of action.

The double-blinded, randomised Phase IIa portion of the trial will analyse the safety and efficacy of the treatment with FMX114 for four weeks in AD patients versus vehicle control. 

The company launched additional trial centres in the US to back subject enrolment and hasten trial completion because of the impact of Covid-19 on enrolment and other activities linked to the original study centres in Australia. 

With the latest development, VYNE plans to report top-line efficacy data from the trial in nearly six to eight weeks.

The company reported positive efficacy findings from the Phase Ib segment of the trial in April this year.

In the trial, FMX114 was found to offer a statistically significant decline in absolute and percent change in mean Atopic Dermatitis Severity Index (ADSI) score versus vehicle. 

In addition, the treatment with FMX114 significantly lowered pruritus (itch) as assessed on the worst pruritus Numerical Rating Scale (NRS).

VYNE Therapeutics CEO David Domzalski said: “We have been encouraged by the early efficacy results from the Phase Ib 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. 

“We look forward to reporting the results of the Phase IIa segment of the study in approximately six to eight weeks.”

A chronic, severe kind of eczema, AD is characterised by the occurrence of dry, red, and itchy skin.