Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Rhea-AI Summary

Dermavant Sciences announced positive results from the Phase 3 PSOARING 3 long-term extension study for tapinarof cream 1% in treating plaque psoriasis. Over 52 weeks, tapinarof showed durable improvements in efficacy, quality of life, and tolerability without irritation. The study demonstrated significant enhancements in key metrics such as % body surface area (%BSA) affected and Psoriasis Area and Severity Index (PASI). Dermavant aims for FDA approval, with a target action date set for Q2 2022, which could position tapinarof as a novel therapeutic option for psoriasis patients.

Positive

• Tapinarof demonstrated continued improvements in efficacy outcomes over 52 weeks.
• Showed no associated tachyphylaxis, indicating sustained effectiveness.
• Well-tolerated by patients with no irritation reported in sensitive areas.
• Potential first-in-class treatment for plaque psoriasis pending FDA approval.

Negative

• None.

• Tapinarof demonstrated continued improvements for up to 52 weeks in efficacy outcomes, quality of life measures, and tolerability scores with no associated tachyphylaxis
  
  
• Tapinarof was well-tolerated in sensitive skin and intertriginous areas with majority of patients experiencing no irritation for up to 52 weeks
• Tapinarof was well tolerated with long term use and demonstrated continued and durable improvement in quality of life
  

LONG BEACH, Calif., and BASEL, Switzerland, March 25, 2022 (GLOBE NEWSWIRE) -- Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced Phase 3 PSOARING 3 long-term extension study results demonstrating durable improvements across efficacy outcomes, quality of life measures, and tolerability scores with investigational tapinarof cream 1% once daily (QD) for the treatment of plaque psoriasis in adults. The data, from prespecified endpoints of the Phase 3 PSOARING 3 long-term extension study, are being presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting, held March 25-29 in Boston.

“Plaque psoriasis is often a lifelong condition that can have a significant negative impact on many aspects of a patient’s life. Due to limitations in current psoriasis therapies, there is a strong need for new topical treatments for adults suffering with this condition,” said April W. Armstrong, M.D., M.P.H., a dermatologist with Keck Medicine of USC and Professor of Dermatology and Associate Dean for Clinical Research in Dermatology at the Keck School of Medicine of USC. “The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging. As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.”

Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3. PSOARING 3 consisted of an additional 40 weeks of open-label intermittent treatment with tapinarof based on Physician Global Assessment (PGA) score, followed by a 4-week follow-up. Patients who were randomized to tapinarof in PSOARING 1 or 2 and who also completed PSOARING 3 received tapinarof treatment for up to 52 weeks.

These newly presented data include prespecified analyses of key secondary efficacy outcomes, quality of life and tolerability assessments. Importantly, continued improvements were observed in all assessments beyond the responses observed in the 12-week pivotal studies. Efficacy outcomes include changes in percentage body surface area (%BSA) affected and in Psoriasis Area and Severity Index (PASI), which is a measurement of the severity and extent of psoriasis. Quality of life outcomes included changes in Dermatology Life Quality Index (DLQI), and tolerability assessments included both patient-reported tolerability and investigator-assessments of irritation at all sites of drug application.

• Investigators rated the majority of patients as having no irritation (score of 0), including those who applied tapinarof to sensitive skin and intertriginous areas at all time points across 40 weeks
• Long-term treatment with tapinarof cream 1% QD for up to 52 weeks demonstrated continued and durable improvement in mean PASI score, PASI75, PASI90, %BSA Affected, DLQI, and local tolerability scores

“We are pleased to report data demonstrating continued improvements in efficacy and patient reported outcomes with use of tapinarof cream 1% once daily, beyond 12 weeks in adults with plaque psoriasis,” said Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant. “These data reinforce the potential tapinarof holds as a possible new treatment option for adults with mild, moderate and severe plaque psoriasis, subject to FDA approval.”

In August 2021, the U.S. Food and Drug Administration accepted a New Drug Application for tapinarof cream 1% for the treatment of plaque psoriasis in adult patients. A Prescription Drug User Fee Act target action date has been assigned in Q2 2022. If approved, tapinarof will be a potential first-in-class, novel small-molecule therapeutic aryl hydrocarbon receptor (“AhR”) modulating agent for adults with plaque psoriasis.

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 tapinarof 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 full analysis results from PSOARING 3 in September 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 small-molecule therapeutic aryl hydrocarbon receptor (AhR) 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).

FAQ

What are the results of the PSOARING 3 study for tapinarof (ROIV,ROIVW)?

The PSOARING 3 study results indicate durable improvements in efficacy, quality of life, and tolerability for tapinarof over 52 weeks.

When is the FDA expected to make a decision on tapinarof (ROIV,ROIVW)?

The FDA has a target action date set for Q2 2022 for tapinarof's New Drug Application.

How long was tapinarof studied in the PSOARING 3 trial (ROIV,ROIVW)?

Patients were studied for up to 52 weeks in the PSOARING 3 trial.

What does the PSOARING 3 trial reveal about the tolerability of tapinarof (ROIV,ROIVW)?

The trial revealed that tapinarof was well tolerated, with the majority experiencing no irritation during treatment.

What are the key efficacy outcomes of tapinarof from the PSOARING 3 study (ROIV,ROIVW)?

Key efficacy outcomes include improved %BSA affected and significant reductions in PASI scores.