April 16, 2021
LONG BEACH, Calif., and BASEL, Switzerland, April 16, 2021—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that two abstracts from Dermavant’s two pivotal Phase 3 trials for tapinarof for the treatment of psoriasis in adults, PSOARING 1 and PSOARING 2, will be presented during the upcoming American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021), on April 23-25, 2021.
Tapinarof is being developed as a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA), cosmetically elegant, steroid-free topical cream for the treatment of plaque psoriasis and atopic dermatitis.
The following posters will be viewable on the conference platform for the entirety of the conference:
Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Secondary Efficacy Outcomes from Two Pivotal Phase 3 Trials
This poster contains secondary efficacy outcomes, including Physician Global Assessment (PGA) scores, percent body surface area (%BSA) affected, and ≥90% reduction in Psoriasis Area and Severity Index (PASI90) – an endpoint more commonly used to assess systemic agents.
Authors: Linda Stein Gold, MD; Andrew Blauvelt, MD, MBA; April Armstrong, MD, MPH; Seemal R. Desai, MD; Howard Sofen, MD; Lawrence J. Green, MD; Stephen K. Tyring, MD, PhD; Laura K. Ferris, MD, PhD; Philip M. Brown, MD, JD; David S. Rubenstein, MD, PhD; Stephen C. Piscitelli, PharmD; Anna M. Tallman, PharmD; Leon Kircik, MD
Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Patient-reported Outcomes from Two Pivotal Phase 3 Trials
This poster contains patient-reported outcomes data, including itch and quality of life measurements.
Authors: Robert Bissonnette, MD; Bruce Strober, MD, PhD; Mark Lebwohl, MD; Jerry Bagel, MD; James Del Rosso, DO; Joseph F. Merola, MD, MMSc; Neal Bhatia, MD; Paul Yamauchi, MD, PhD; Philip M. Brown, MD, JD; David S. Rubenstein, MD, PhD; Anna M. Tallman, PharmD; Stephen C. Piscitelli, PharmD
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), as well as PSOARING 3 (NCT04053387), the ongoing long-term safety study.
PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
PSOARING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Subjects in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consists of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, subjects who receiveddrug during PSOARING 1 and PSOARING 2, completed PSOARING 3 having received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
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 United States 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 earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, 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 26 million people in the United States, respectively. The company reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).