Enrollment complete in tapinarof safety study for plaque psoriasis
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Dermavant Sciences has completed enrollment in a long-term safety study of tapinarof for treatment of plaque psoriasis, the company announced in a press release.
As part of an ongoing phase 3 program, tapinarof, a once-daily topical aryl hydrocarbon receptor modulating agent, is also in two clinical trials, PSOARING 1 and PSOARING 2, evaluating efficacy and safety, the release said.
“The long-term safety study is intended to produce extended evidence for the safety profile of tapinarof and its potential efficacy over time. The completion of enrollment for this study marks yet another important milestone for Dermavant and brings us one step closer to a potential NDA submission for tapinarof to the FDA,” Todd Zavodnick, Dermavant CEO, said in the release. “Notably, early observations of participation and retention rates for our long-term safety study have been favorable, which we believe point to the potential of tapinarof as a novel and potentially first-in-class, single therapy treatment option for psoriasis patients.”
After 12 weeks of treatment in the PSOARING trials, eligible patients could enroll in the long-term safety study, which will include 40 weeks of follow-up; 91% of patients in the trials decided to enroll in the safety study.