VYNE Therapeutics announces FDA clearance of IND application for VYN202

VYNE Therapeutics announced the clearance of its Investigational New Drug application, IND, by the U.S. Food and Drug Administration for VYN202, an oral BD2-selective BET inhibitor. VYNE plans to initiate a first-in-human Phase 1a single ascending dose/multiple ascending dose trial in healthy volunteers this quarter and expects to report top line results from the SAD/MAD trial in the second half of this year. “VYN202 is a highly selective and potent orally administered BET inhibitor that we believe has significant potential as a treatment option for autoimmune diseases. Clearance of the IND for VYN202 marks a major step forward in this effort,” said David Domzalski, President and CEO of VYNE. “We look forward to initiating the Phase 1a trial in the coming weeks to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202.”