VYNE Therapeutics has reported positive data from the Phase Ia portion of its Phase Ia/b study of VYN201, the company’s new BET inhibitor, to treat the chronic autoimmune depigmenting skin disorder vitiligo.
Single and multiple ascending doses of VYN201 were applied topically to 30 healthy subjects in the Phase 1a portion.
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These healthy volunteers received the doses once daily in five dose cohorts for a period of two weeks.
The trial also had a one-week safety follow-up visit for assessing the tolerability, safety, and pharmacokinetics of VYN201.
Evaluated doses of the BET inhibitor included 0.025%, 0.1%, 0.5%, 1%, and 2% ointment strengths.
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No serious adverse events were reported in the trial and no dose adjustments were required.
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By GlobalDataThe trial also reported no clinically relevant treatment emergent adverse events, electrocardiogram findings, or abnormal clinical laboratory results.
Additionally, it was observed that no healthy volunteers in the trial withdrew for any reason.
VYNE has selected ointment strengths of 0.5%, 1%, and 2% for evaluation in the Phase Ib study underway that is evaluating VYN201 in non-segmental vitiligo patients.
In the trial’s Phase 1b portion, up to 30 patients with a clinical non-segmental vitiligo diagnosis will be given VYN201 once-a-day in three dose cohorts.
Assessing the safety and pharmacokinetics of VYN201 will be the primary objective of this portion of the trial.
Exploratory efficacy of VYN201 will also be evaluated in non-segmental vitiligo patients, including pharmacodynamic biomarkers and photography.
VYNE Therapeutics president and CEO David Domzalski said: “These preliminary safety results mark a significant milestone as we progress our first in-human clinical trial for VYN201 and advance the development of our BET inhibitor programmes for immuno-inflammatory indications.
“These safety data support our thesis for designing VYN201 as a locally-administered soft drug to minimise systemic exposure and maximise target engagement, and we look forward to receiving topline results from the Phase 1b portion of the study in the middle part of the year.”
In June last year, VYNE Therapeutics completed subject enrolment in the Phase IIa clinical trial of FMX114 to treat mild-to-moderate atopic dermatitis.
