October 22, 2020
– A Poster on the MUPK Study for Tapinarof Also to be Presented
– Tapinarof is a Potential First-in-Class Psoriasis Treatment with a Novel Mechanism of Action
– To Date, Over 2,200 Subjects Have Enrolled in 18 Clinical Trials of Tapinarof
– New Drug Application Filing Anticipated in 2021
LONG BEACH, Calif., and BASEL, Switzerland, October 22, 2020—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that two posters on tapinarof will be presented during the upcoming 2020 Fall Clinical Dermatology Conference to be held virtually Oct. 29-Nov. 1, 2020. The two presentations will cover data from Dermavant’s successful Phase 3 PSOARING pivotal trials in addition to a maximal use pharmacokinetics study.
“Having recently reported positive Phase 3 PSOARING 1 and PSOARING 2 results for tapinarof cream 1% in adult patients with plaque psoriasis, we are excited to share these efficacy and safety data at Fall Clinical,” said David Rubenstein, MD, PhD, Chief Scientific Officer of Dermavant. “These study outcomes reinforce the potential, subject to approval by the U.S. Food and Drug Administration, of tapinarof, a non-steroidal topical cream, to become a first-line treatment option for patients with plaque psoriasis. I would like to thank everyone who has been involved in the PSOARING program.”
The following digital posters will be viewable on the conference platform for the entirety of the conference:
Maximal Use Study of Tapinarof Cream 1% in Subjects with Extensive Plaque Psoriasis
John E. Jett, PhD; Michael McLaughlin, MS, MSE, RAC; Mark S. Lee, MD; Lawrence Charles Parish, MD, MD (Hon), MA; Glenn Tabolt, MS; Timothy Wilson, MS; Matthew C. Somerville, MS; Wayne DellaMaestra, MS; Stephen C. Piscitelli, PharmD
Tapinarof Cream 1% QD for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials
Mark Lebwohl, MD; Linda Stein Gold, MD; Bruce Strober, MD, PhD; April Armstrong, MD, MPH; H. Chih-ho Hong, MD, FRCPC; Leon Kircik, MD; Jennifer Soung, MD; Jeff Fromowitz, MD, FAAD; Scott Guenthner, MD; Stephen C. Piscitelli, PharmD; David S. Rubenstein, MD, PhD; Philip M. Brown, MD, JD; Anna M. Tallman, PharmD; Robert Bissonnette, MD
Tapinarof is a potential first-in-class, steroid-free, cosmetically elegant, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream being developed for the treatment of plaque psoriasis and atopic dermatitis. To date, over 2,200 subjects have enrolled in 18 clinical trials of tapinarof.
In late August, Dermavant announced positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. The 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), an ongoing long-term safety study.
Tapinarof previously met the primary endpoints 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).
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 27 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).