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VYNE Therapeutics Announces Positive Results from Phase 1a Single and Multiple Ascending Dose Trial for Investigational Novel BET Inhibitor VYN201
VYN201 was generally well-tolerated with no clinically relevant treatment emergent adverse events from all dose cohorts, meeting the primary objective of the
About this update from Vyne Therapeutics Inc.
[{"type":"text","content":"VYN201 was generally well-tolerated with no clinically relevant treatment emergent adverse events from all dose cohorts, meeting the primary objective of the study Topline Phase 1b results in vitiligo patients expected in mid-2023 BRIDGEWATER, N.J., Feb. 15, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced positive results from the Phase 1a portion of its Phase 1a/b clinical trial evaluating its novel BET inhibitor, VYN201, for vitiligo. In the Phase 1a portion of the study, single ascending and multiple ascending doses of VYN201 were applied topically once daily to 30 healthy volunteers in five dose cohorts for two weeks with a one-week safety follow-up visit to evaluate the safety, tolerability and pharmacokinetics of VYN201. Evaluated doses included VYN201 0.025%, 0.1%, 0.5%, 1.0% and 2.0% ointment strengths. The safety and tolerability results are summarized below: There were no serious adverse events and no dose adjustments were required.There were no clinically relevant treatment emergent adverse events, abnormal clinical laboratory results or electrocardiogram findings.No healthy volunteers withdrew from the trial for any reason.VYNE has selected 0.5%, 1.0% and 2.0% ointment strengths for evaluation in the ongoing Phase 1b study evaluating VYN201 in non-segmental vitiligo patients. In the Phase 1b portion of the study, up to 30 patients with a clinical diagnosis of non-segmental vitiligo will receive VYN201 once daily in three dose cohorts. The primary objective of the Phase 1b portion of the study will be to evaluate the safety and pharmacokinetics of VYN201. Exploratory efficacy of VYN201 in non-segmental vitiligo patients will also be evaluated, including pharmacodynamic biomarkers and photography. “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 programs for immuno-inflammatory indications,” said David Domzalski, President and Chief Executive Officer of VYNE. “These safety data support our thesis for designing VYN201 as a locally-administered soft drug to minimize systemic exposure and maximize tar...