Dermavant Sciences completed patient enrollment in PSOARING 1 and PSOARING 2 clinical trials of tapinarof, a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA), in adult patients diagnosed with plaque psoriasis.
Dermavant expects to announce results for PSOARING 1 and PSOARING 2 in the second half of 2020.
“I’m excited to announce the completion of enrollment for our PSOARING Phase 3 clinical trials of tapinarof for the treatment of adult plaque psoriasis, one of the largest topical programs ever undertaken in this indication,” says Todd Zavodnick, Chief Executive Officer of Dermavant, ina news release. “We believe tapinarof could be a highly differentiated psoriasis offering, potentially as the first topical with a novel mechanism of action in over 20 years, which makes today’s announcement an important milestone not just for the company, but for the psoriasis community as well. Tapinarof has now been dosed in over 1,700 subjects to date, and we believe it to be one of the most promising and cost-efficient therapeutics in dermatology today.”
Contingent upon positive results from the PSOARING 1 and PSOARING 2 Phase 3 clinical trials, and subject to the completion and findings of a 52-week long-term safety study, Dermavant expects to file a New Drug Application (NDA) for tapinarof topical cream for the treatment of plaque psoriasis with the U.S. Food and Drug Administration (FDA) in 2021. Dermavant also plans to initiate Phase 3 clinical studies of tapinarof in atopic dermatitis.
While any marketing approval will be based on the overall results of the trials, the company expects approval for tapinarof in adult plaque psoriasis in the U.S. will require that the PSOARING trials (PSOARING 1 and PSOARING 2) demonstrate that tapinarof produces a statistically significant improvement relative to vehicle in its primary outcome measure, which is the proportion of patients who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
Tapinarof previously demonstrated clinically meaningful and statistically significant responses in separate Phase 2b trials for plaque psoriasis and atopic dermatitis. Both studies were published in The Journal of the American Academy of Dermatology (JAAD).
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 and PSOARING 2, plus a long-term safety study.
The PSOARING studies, PSOARING 1 and PSOARING 2, which have together enrolled 1,025 patients, are identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies to evaluate the safety and efficacy of tapinarof cream 1% dosed once daily (QD) for 12 weeks versus vehicle in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies is a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
Following the 12-week, vehicle-controlled portion of PSOARING 1 and PSOARING 2, patients have the option to enroll in a separate, open-label extension study for an additional 40 weeks of treatment.