Patient enrollment complete for tapinarof long-term safety study for psoriasis

Jun 12, 2020, 4:15pm

Dermavant announces the enrollment completion for their long-term safety study investigating tapinarof in adults with plaque psoriasis as a part of the PSOARING 1 and PSOARING 2 phase 3 program.

Dermavant has announced completion of enrollment in their long-term safety study of tapinarof (GSK2894512, Dermavant) for treatment of psoriasis as a part of a phase 3 program.

The long-term study is a part of the PSOARING 1and PSOARING 2 phase 3 trials investigating the efficacy and safety of tapinarof in adult patients with plaque psoriasis.

Tapinarof 1% cream is a potential first-in-class topical with a novel mechanism of action, which inhibits many of the proinflammatory mediators associated with inflammation and has been shown to enhance the skin barrier function, according to the company.1 The drug is currently being evaluated for psoriasis and atopic dermatitis.

MORE: Tapinarof cream demonstrates positive phase 2b result

A total of 1,025 patients have been enrolled in the PSOARING 1 and PSOARING 2 trials. Following 12 weeks of treatment, subjects will have the choice to enroll in a separate study for an additional 40 weeks. Dermavant reports that 91% of subjects who have completed the PSOARING 1 and 2 trials have elected to enroll in the long-term safety study.

“The long-term safety study is intended to produce extended evidence for the safety profile of tapinarof and its potential efficacy over time. The completion of enrollment for this study marks yet another important milestone for Dermavant and brings us one step closer to a potential NDA submission for tapinarof to the FDA,” says Todd Zavodnick, CEO of Dermavant. “Notably, early observations of participation and retention rates for our long-term safety study have been favorable, which we believe point to the potential of tapinarof as a novel and potentially first-in-class, single therapy treatment option for psoriasis patients.”

Most recently, Dermavant published results in the Journal of the American Academy of Dermatology (JAAD) from their phase 2b study investigating tapinarof 1% in adults with mild, moderate and severe plaque psoriasis that covered between 1% and 15% of their body surface area.

As recently reported by Dermatology Times, results from the study demonstrate a Psoriasis Area and Severity Index (PASI) 75 improvement score as early as week two in tapinarof 1% QD (n=25) and statically significant by week eight, as well as maintained for four weeks post discontinuing treatment versus vehicle QD (n=20) (p<0.001 at week 12).2

Also, a PASI90 score was reported statically significant at week 12 with tapinarof 1% QD (n=25), including demonstrating efficacy and maintenance through week 16 compared to vehicle QD (n=20) (p=0.001 at week 12).2

RELATED: Patient enrollment completed for Dermavant phase 3 psoriasis clinical trials

“As a dermatologist who sees firsthand the debilitating effects psoriasis can have on patients, I am excited to see tapinarof achieve this milestone, since it brings this innovative treatment option one step closer to the patients who need it,” says Bruce Strober, M.D., Ph.D., clinical professor of dermatology at Yale University School of Medicine and Central Connecticut Dermatology. “I believe tapinarof could represent an important advancement in the treatment choices for psoriasis and atopic dermatitis. My hope is that I, along with my colleagues, will have access to this novel topical therapy in the future.”

The company says they will announce results from both PSOARING 1 and 2 in the second half of 2020, as well as results from the safety study in the second half of 2021, according to the press release.1