Business
VYNE Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update
Anticipate topline 16-week data for all three cohorts from the Phase 1b trial for pan-BD BET inhibitor, VYN201, in nonsegmental vitiligo in the third quarter
About this update from Vyne Therapeutics Inc.
[{"type":"text","content":"Anticipate topline 16-week data for all three cohorts from the Phase 1b trial for pan-BD BET inhibitor, VYN201, in nonsegmental vitiligo in the third quarter of 2023 IND-enabling studies for VYN202, a potential best-in-class oral small molecule BD2-selective BET inhibitor, are ongoing in anticipation of an IND filing by year-end 2023 BRIDGEWATER, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results for the three months ended March 31, 2023 and provided a business update. “We continue to build significant momentum in advancing our proprietary pipeline of novel, small molecule BET inhibitors for the treatment of immuno-inflammatory conditions,” said David Domzalski, President and Chief Executive Officer of VYNE. “During the first quarter, we generated important new clinical data for VYN201, demonstrating positive safety results and pharmacokinetic results in healthy volunteers. Additionally, we successfully completed our six-month animal toxicology study for VYN201, which allowed us to extend the duration of our Phase 1b trial in vitiligo patients from 8 weeks to 16 weeks. We are encouraged by the progress we have made to date, and we are narrowing our timing guidance for topline 16-week data for all three cohorts from the Phase 1b portion of the trial to the third quarter of 2023. In addition, we recently expanded our BET inhibitor pipeline after selecting a development candidate for our first oral BET inhibitor program, VYN202. We look forward to completing our IND-enabling studies for VYN202 in the coming months, selecting a lead indication, and submitting our first IND filing by the end of the year.” Recent Business Updates VYN201, locally-administered pan-BD BET inhibitor: Positive safety, tolerability, pharmacokinetic and hematology data from Phase 1a trial in healthy volunteers. In February, VYNE announced data from its Phase 1a trial showing that dosing with topical VYN201 did not produce any serious adverse events or require dose adjustments. Furthermore, there were no clinically relevant treatment emergent adverse events, abnormal clinical laboratory results, electrocar...