- Top-line data is anticipated in the first half of 2020
- If PSOARING trials are successful, a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA) is anticipated in 2021
BASEL, Switzerland and PHOENIX, June 5, 2019 (GLOBE NEWSWIRE)—Dermavant Sciences, a dermatology-focused subsidiary of Roivant Sciences, today announced that the first patient has been dosed in its pivotal Phase 3 psoriasis clinical program, PSOARING, for its lead product candidate, tapinarof. Tapinarof is a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream being developed by Dermavant for plaque psoriasis and atopic dermatitis. If the PSOARING trials are successful, the Company anticipates submitting the NDA for tapinarof for the treatment of plaque psoriasis to the FDA in 2021.
“We are excited to announce the first patient dosed in our PSOARING trials and expect to report top-line results in the first half of 2020,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Having already been dosed in over 600 patients across 10 different clinical trials and having met all primary endpoints in five Phase 2 clinical trials, we believe tapinarof is one of the most promising advanced development product candidates in dermatology today and, if approved, could potentially provide new options to patients suffering from psoriasis.”
PSOARING is Dermavant’s pivotal Phase 3 psoriasis clinical program for tapinarof, which consists of two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies—PSOARING 1 and PSOARING 2—to evaluate the safety and efficacy of tapinarof cream 1% dosed once daily (QD) for 12 weeks versus vehicle in adult patients aged 18-75 years diagnosed with plaque psoriasis.
The primary endpoint of both studies will be a Physician Global Assessment (PGA) score assessment of “clear” skin (score of 0) or “almost clear” skin (score of 1), plus at least a 2-grade improvement from baseline, at Week 12. Following the 12-week, vehicle-controlled portion of the PSOARING trials, patients will have the option to enroll in a separate, open-label extension study for an additional 40 weeks of treatment.
Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology. Dermavant leverages the Roivant platform 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 differentiated therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 7.5 million and 28 million people in the United States, respectively. For more information, please visit www.dermavant.com.
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.
About Roivant Pharma
Roivant Pharma is the biopharmaceutical business unit of Roivant Sciences. Roivant Pharma is focused on end-to-end biopharmaceutical company creation, launch, and oversight. Roivant Pharma companies include Altavant, Aruvant, Axovant, Dermavant, Enzyvant, Genevant, Immunovant, Metavant, Myovant, Respivant, Urovant, and Arbutus.