LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its Phase 3 PSOARING long-term extension study at the 30th European Academy of Dermatology and Venerology (EADV) Virtual Congress, to be held September 29 through October 2, 2021. The data have been selected for a late-breaking oral presentation.
The presentation will contain efficacy and safety outcomes designed to assess the duration of remittive effect off therapy and durability of response on therapy with long-term use of once daily tapinarof cream 1% beyond the 12-week pivotal studies.
The PSOARING 3 study evaluated tapinarof as a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent, steroid-free topical cream for the treatment of plaque psoriasis in adult patients. In August, the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New Drug Application for tapinarof for the treatment of plaque psoriasis in adult patients. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.
Oral Presentation Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: A Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent
Date and Time of Presentation: Thursday, September 30 at 9:45-10:00 am EDT, 15:45-16:00 pm CET
Location: Virtual Room 1
Presenter: Linda Stein Gold, MD
Authors: Bruce Strober, Linda Stein Gold, Robert Bissonnette, April Armstrong, Andrew Blauvelt, Leon Kircik, Philip M Brown, Anna M Tallman, Mark Lebwohl.
The presentation and subsequent question-and-answer session can be viewed live by registering for the event on the EADV website.
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), a long-term extension 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 the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
PSOARING 3 was 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. Patients 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 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3 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. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.
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. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant 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 has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).