June 9, 2020
LONG BEACH, Calif., and BASEL, Switzerland, June 9, 2020—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced the completion of patient enrollment in the company’s long-term safety study of tapinarof, a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA), 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,” said 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,” said Bruce Strober, M.D., Ph.D., 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 can 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.
Tapinarof previously demonstrated clinically meaningful and statistically significant responses in separate Phase 2b trials for plaque psoriasis and atopic dermatitis. Both studies were published in The Journal of the American Academy of Dermatology (JAAD), the official, peer-reviewed, scientific publication of the American Academy of Dermatology (AAD).
About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis
Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), plus a long-term safety study.
The PSOARING studies, PSOARING 1 and PSOARING 2, which have together enrolled 1,025 adult patients aged 18-75 years diagnosed with plaque psoriasis, are identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies to evaluate the safety and efficacy of tapinarof cream 1% dosed once daily (QD) for 12 weeks versus vehicle. The primary endpoint of both studies is a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline at Week 12.
Following the 12-week, vehicle-controlled portion of PSOARING 1 and PSOARING 2, patients have the option to enroll in a separate, open-label extension study for an additional 40 weeks of treatment.
Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the U.S. and 125 million worldwide.
Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.
Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, psoriasis and atopic dermatitis, as well as other large markets, including vitiligo, primary focal hyperhidrosis, and acne. Dermavant is developing its lead product candidate, tapinarof (DMVT-505), as a novel therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 28 million people in the United States, respectively. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).