01/15/2022 | Press release | Distributed by Public on 01/15/2022 05:16
January 15, 2022
- Patients from PSOARING 3 who completed the survey preferred tapinarof to prior topical treatments with 81.7% considering it more effective -
LONG BEACH, Calif., and BASEL, Switzerland, January 15, 2022-Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced results from a patient satisfaction questionnaire in the long-term, open-label Phase 3 PSOARING 3 extension study of tapinarof cream 1% once daily for the treatment of plaque psoriasis in adults. Patient responses demonstrated consistent high rates of satisfaction and positive perception of treatment with tapinarof across all patient-relevant parameters, including patient satisfaction with treatment efficacy, formulation elegance, ease of application, impact on daily life and preference for tapinarof versus prior psoriasis therapies. These results were presented during the 2022 Winter Clinical Dermatology Conference, held January 14-19 in Koloa, Hawaii.
"As a clinician, it's paramount that my patients are satisfied with their treatment, as research shows that patients who are satisfied with their treatment are more likely to continue treatment, which may improve treatment efficacy. I am encouraged by these results with tapinarof showing consistent patient satisfaction, which has often been difficult to achieve with current psoriasis treatments, including steroidal topicals," said Jerry Bagel, M.D., M.S., director of the Psoriasis Treatment Center of New Jersey and Eczema Treatment Center of New Jersey in East Windsor, a member of the National Psoriasis Foundation board of directors, and lead author of this publication. "Building on previous PSOARING 3 results, these findings demonstrate that tapinarof, subject to FDA approval, has the potential to be a long-awaited new treatment option to improve the care of patients suffering from this debilitating, chronic condition."
Responses to the questionnaire, which were assessed at study completion (week 40 or early termination), demonstrated consistent high rates of satisfaction across all evaluated parameters. Of the 78.5% (n=599) of patients from PSOARING 3 who completed the survey:
"As a team that is driven by a passion for helping patients, we are delighted to present findings for patient satisfaction with tapinarof from PSOARING 3 during the 2022 Winter Clinical Dermatology Conference, highlighting our continued commitment to addressing unmet needs for patients with inflammatory skin conditions," said Philip M. Brown, M.D., J.D., Chief Medical Officer of Dermavant. "We know that patients with plaque psoriasis and their physicians are looking for non-steroidal topical treatment options, and we hope to bring long-overdue innovation to this community."
In August 2021, the FDA accepted a New Drug Application for tapinarof for the treatment of plaque psoriasis in adult patients and assigned a Prescription Drug User Fee Act target action date in Q2 2022.
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 the drug during PSOARING 1 and PSOARING 2 and who 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. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).