Dermavant Presents New Patient Satisfaction Data from Tapinarof’s PSOARING 3 Long-Term Extension Trial in Adults With Plaque Psoriasis at Winter 2022 Clinical Dermatology Conference

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LONG BEACH, CA & BASEL, Switzerland–(BUSINESS WIRE)–Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative immuno-dermatology therapies, today announced the results of a patient satisfaction questionnaire as part of the study of long-term, open-label Phase 3 extension PSOARING 3 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 tapinarof treatment across all patient-relevant parameters, including patient satisfaction with treatment efficacy, elegance of formulation , ease of application, impact on daily life, and preference for tapinarof over previous psoriasis treatments. These results were presented at the 2022 Clinical Dermatology Winter Conference, held January 14-19 in Koloa, Hawaii.

“As a clinician, it is 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 can improve treatment effectiveness. I am encouraged by these results with tapinarof showing consistent patient satisfaction, which has often been difficult to achieve with current psoriasis treatments, including topical steroids,” said Jerry Bagel, MD, MS, director of Psoriasis Treatment. Center of New Jersey and Eczema Treatment. Center of New Jersey in East Windsor, board member of the National Psoriasis Foundation and senior author of this publication. “Building on previous PSOARING 3 results, these results demonstrate that tapinarof, pending FDA approval, has the potential to be a long-awaited new treatment option to improve care for patients with of this chronic debilitating disease.”

The questionnaire responses, which were assessed at the end of the study (week 40 or early termination), demonstrated consistently high satisfaction rates for all parameters assessed. Of the 78.5% (599/763) of PSOARING 3 patients who responded to the survey:

  • Patients preferred tapinarof over previous topical treatments, with 81.7% considering it more effective.

  • 85.8% strongly agreed or agreed that they could easily manage their psoriasis with tapinarof.

  • 82.5% said they would use tapinarof again or continue to use it if it were available.

“As a team driven by a passion to help patients, we are thrilled to present the results of patient satisfaction with PSOARING 3’s tapinarof at the Winter 2022 Clinical Dermatology Conference, underscoring our continued commitment address the unmet needs of patients with inflammatory skin conditions.” said Philip M. Brown, MD, JD, Dermavant’s Chief Medical Officer. “We know that patients with plaque psoriasis and their physicians are looking for nonsteroidal topical treatment options, and we hope to bring long-awaited 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 target action date under the Prescription Drug User Fee Act 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 includes 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 1025 patients, were two identically designed, multicenter, randomized, vehicle-controlled, double-blind, parallel-group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% administered once daily (QD) for 12 weeks compared to vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients achieving a clear (0) or nearly clear (1) PGA score 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. Study patients had previously completed treatment with tapinarof or vehicle in the pivotal Phase 3 efficacy and safety studies PSOARING 1 or PSOARING 2. PSOARING 3 included up to 40 weeks of tapinarof cream at 1 % and a safety follow-up period of 4 weeks. Thus, patients who received medication during PSOARING 1 and PSOARING 2 and who completed PSOARING 3 received treatment with tapinarof cream for up to 52 weeks. Over 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim PSOARING 3 results in February 2021 and the study ended on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and patches with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can start at any age, but generally has two peaks of onset, the first between 20 and 30 years old and the second between 50 and 60 years old. People with psoriasis are at an increased risk of developing other chronic and serious health problems. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative therapies in immuno-dermatology. Dermavant’s goal is to develop therapies that have the potential to address unmet medical needs while improving the efficiency of clinical research and development. The Company’s strong medical dermatology product portfolio includes both late-stage and early-stage product candidates that the Company believes could treat important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis and acne. Tapinarof is a novel aryl hydrocarbon receptor modulating therapeutic agent being developed as a once-daily, steroid-free, aesthetically pleasing topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect an estimated 8 million and 26 million people in the United States. states, respectively. The company reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, visit www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

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