The U.S. FDA has verbally informed Vyne Therapeutics that it placed a clinical hold on the company’s phase 1b study evaluating Vyne’s BET inhibitor for the treatment of moderate-to-severe plaque psoriasis, following a recent observation of testicular toxicity in dogs from a non-clinical study.
Vyne has suspended all screening, enrollment and patient dosing in the phase 1b trial — which kicked off in February — and intends to work with the FDA to resolve the clinical hold. To date, there have been no serious adverse events observed in subjects that have been enrolled in the phase 1b study.
YN202 is an oral small molecule BD2-selective bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immune-mediated diseases.
Vyne noted that the hold does not apply to the company’s ongoing phase 2b trial of repibresib gel — a compound made from VYN202 — being tested in nonsegmental vitiligo.