Dermavant to Present New Data from Phase 3 PSOARING Program at the 2022 Winter Clinical Dermatology Conference

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The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.

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Friday, January 7, 2022
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Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, People, Grand Promenade, Safety, QD, Acne, Atopic dermatitis, Food, Poster, Vitiligo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Psoriasis, Skin, Therapy, Roivant Sciences, Depression, Research, Patient, Adult, Inflammatory bowel disease, PDUFA, Obesity, Quality of life, Conference, Twitter, Ageing, Week, Efficiency, PGA, Diabetes, Hypertension, LinkedIn, FDA, New Drug Application, Risk, Pharmaceutical industry, Dermavant’s Phase 3 Program for Tapinarof in Psoriasis, Psoriasis, Dermavant, DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT
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SWITZERLAND, NORTH AMERICA, KOLOA, HAWAII, UNITED STATES
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DERMAVANT’S PHASE 3 PROGRAM FOR TAPINAROF IN PSORIASIS, PSORIASIS, DERMAVANT
Summary
Key Points: 
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.
  • Dermavants 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.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • For more information, please visit www.dermavant.com , and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ).


Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that new patient satisfaction data from PSOARING 3, the long-term extension study of tapinarof cream for the treatment of plaque psoriasis in adults, will be presented at the 2022 Winter Clinical Dermatology Conference, to be held Jan. 14-19 in Koloa, Hawaii.

Tapinarof is as a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent. It is being developed in a cosmetically elegant, steroid-free topical cream for the treatment of plaque psoriasis and atopic dermatitis. In August 2021, 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 adults. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022.

The following poster will be viewable at the Poster Gallery in the Grand Promenade of the Grand Hyatt Kauai at the following dates and times:

  • Saturday, January 15, 2022: 7:00 AM – 6:30 PM HST
  • Sunday, January 16, 2022: 6:30 AM –7:00 PM HST
  • Monday, January 17, 2022: 6:45 AM – 12:00 PM HST

Title: Patient Satisfaction with Tapinarof Cream 1% Once Daily for Plaque Psoriasis in a Long-Term Extension Trial

This poster will report data from a Patient Satisfaction Questionnaire, administered at study completion, designed to assess patient satisfaction with tapinarof efficacy, formulation elegance, application ease, impact on daily life and preference for tapinarof versus prior psoriasis therapies.

Authors: Jerry Bagel, M.D.; Linda Stein Gold, M.D.; James Del Rosso, D.O.; Neal Bhatia, M.D.; Sandy Johnson, M.D.; Paul Yamauchi, M.D., Ph.D.; Angela Y. Moore, M.D.; Anna M. Tallman, Pharm.D.

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 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. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

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.

About Dermavant

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. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

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