October 27, 2020
– 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 27, 2020—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the European Academy of Dermatology and Venereology (EADV) has selected an abstract submission on the pivotal PSOARING data for tapinarof as a late-breaking oral presentation at the 29th EADV Congress to be held virtually Oct. 29-31, 2020.
The presentation, titled “Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials,” will be delivered on Saturday, Oct. 31, 10:15-10:30 am ET, 15:15-15:30 CET, in the virtual Alibert Room by Mark Lebwohl, MD, Dean for Clinical Therapeutics and Waldman Professor and Chairman of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York.
“We are honored to be selected by the EADV to present these late-breaking data,” said Philip Brown, MD, JD, Chief Medical Officer of Dermavant. “Our Phase 3 PSOARING 1 and PSOARING 2 data for tapinarof cream are very compelling, and appropriate for this year’s EADV theme of ‘new frontiers in dermatology and venereology.’ We very much look forward to sharing the results with the dermatology community.”
“As the lead investigator for PSOARING 1, it is a privilege to present these exciting findings from the Phase 3 pivotal trials of tapinarof cream, a potential new treatment option for psoriasis, to my esteemed dermatology colleagues at EADV,” said Dr. Lebwohl.
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).
Dr. Lebwohl is a paid consultant by Dermavant.