$VYNE reported that its Phase 2b trial of Repibresib gel in nonsegmental vitiligo failed to meet its primary and key secondary endpoints (F-VASI50 and F-VASI75) at week 24. Though the 3% dose showed nominally significant improvements in percent change from baseline in F-VASI and https://t.co/XrHrtNsT5p
VYNE Therapeutics Announces Topline Results from Phase 2b Trial with Repibresib Gel in Nonsegmental Vitiligo $VYNE https://t.co/l8BAqPGzow
$VYNE Announces Topline Results from Phase 2b Trial with Repibresib Gel in Nonsegmental Vitiligo. Trial Did Not Meet Primary Endpoint or Key Secondary Endpoint of F-VASI50 and F-VASI75 Company Will Terminate Extension Phase of Trial
VYNE Therapeutics said its Phase 2b study of Repibresib gel in 177 adults with nonsegmental vitiligo failed to reach the trial’s main goal—achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at Week 24—compared with a vehicle control. The treatment also missed the key secondary endpoint of a 75% improvement (F-VASI75). While the 3% concentration delivered a nominally significant 43.6% mean reduction in facial depigmentation versus 25.6% for vehicle, the company attributed the overall shortfall to an unusually high response in the placebo arm and higher-than-expected dropout rates in active cohorts. On the back of the data, VYNE will discontinue dosing in the trial’s extension phase and look for an external partner to continue developing the topical BET inhibitor. Management said it expects to end the second quarter with about $39.6 million in cash, pending final results. The disappointing readout sent VYNE shares tumbling roughly 45% in pre-market trading on Wednesday before the stock was temporarily halted.