Dermavant Submits New Drug Application (NDA) to FDA for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis

June 3, 2021 12:00 UTC

 

- NDA is supported by positive data from the Phase 3 PSOARING 1 and PSOARING 2 pivotal efficacy trials and interim results from the PSOARING 3 long-term safety study -

 

LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapinarof for the treatment of mild, moderate and severe plaque psoriasis in adult patients.

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. The FDA has a 60-day review period to determine whether the NDA is complete and acceptable for filing. The company submitted the NDA to the FDA on May 26, 2021.

“Psoriasis impacts approximately 8 million Americans, who have to navigate the physical and emotional toll from this devastating disease,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Today’s NDA submission marks a significant milestone as we work toward FDA approval of tapinarof for adults with plaque psoriasis and their dermatologists who are looking to fill current treatment gaps. We plan on continuing our commercial preparations to bring this novel product candidate to the U.S. market as expeditiously as possible, subject to regulatory approval.”

Today’s submission is supported by positive Phase 3 data from PSOARING 1 and PSOARING 2, two replicate, multi-center, randomized, vehicle-controlled, double-blind studies, as well as the interim results from PSOARING 3, a 40-week, open-label safety study. In these studies, treatment with tapinarof cream led to statistically significant improvement relative to vehicle in Physician Global Assessment (PGA) scores of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at week 12, with statistically significant improvement in all secondary endpoints at week 12. Approximately 40% of patients achieved complete disease clearance with continued therapy beyond 12 weeks. In addition, a remittive benefit of approximately four months was observed following treatment discontinuation.

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), the ongoing long-term safety 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 is 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. Subjects 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 consists of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, subjects 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.

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).

Contacts

Gilmartin:
Laurence Watts
Managing Director
laurence@gilmartinir.com
619-916-7620

dna Communications:
Angela Salerno-Robin
Senior Vice President, Media Relations, Healthcare
ASalerno-Robin@dna-comms.com
212-445-8219

 
 

Source: Dermavant Sciences

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