Patient enrollment in Dermavant’s long-term safety study of tapinarof is now complete, the company says. Tapinarof is a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) being investigated for use in adult patients diagnosed with plaque psoriasis.
The long-term safety study is part of the Phase 3 program for tapinarof, which also includes PSOARING 1 and PSOARING 2—two identical Phase 3 clinical trials to evaluate the efficacy and safety of tapinarof in adult patients with plaque psoriasis. Dermavant has now completed patient enrollment for PSOARING 1 and PSOARING 2 as well as the long-term safety study. The company expects to announce topline results from PSOARING 1 and PSOARING 2 in the second half of 2020, and to complete the long-term safety study in the second half of 2021. To date, the company’s clinical trials have not been materially impacted by COVID-19.
“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,” says Todd Zavodnick, Chief Executive Officer of Dermavant. “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.”
"As a dermatologist who sees firsthand the debilitating effects psoriasis can have on patients, I am excited to see tapinarof achieve this milestone, since it brings this innovative treatment option one step closer to the patients who need it,” says Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine and Central Connecticut Dermatology. “I believe tapinarof could represent an important advancement in the treatment choices for psoriasis and atopic dermatitis. My hope is that I, along with my colleagues, will have access to this novel topical therapy in the future.”
Eligible patients could elect to enroll into the long-term safety study after 12 weeks of treatment in the PSOARING 1 or PSOARING 2 trials. From the 12 week baseline, and throughout the subsequent 40 weeks, the study aims to evaluate multiple outcome measures of the long-term safety, efficacy and sustained response of tapinarof. Of those patients who completed PSOARING 1 and PSOARING 2, 91% elected to continue in the long-term safety study.