Positive results from a planned interim analysis of PSOARING 3, Dermavant Sciences’ long-term, open-label safety study, show that approximately 40 percent of subjects treated with investigational tapinarof cream, 1% achieved complete disease clearance (PGA score = 0). Treatment was well tolerated and no increased risk of AEs was observed with longer use of the topical agent. 

Tapinarof is a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) formulated in a cosmetically elegant, steroid-free topical cream, that Dermavant is developing for plaque psoriasis and atopic dermatitis.

Data from this interim analysis will be included in the company’s prospective New Drug Application (NDA) submission to the FDA. Dermavant expects to complete the PSOARING 3 long-term safety study in the first half of 2021, with an NDA submission in the middle of this year. Additional data from the PSOARING 1 and PSOARING 2 pivotal efficacy trials, have been reported. The three trials comprise Dermavant’s Phase 3 program for tapinarof in adult patients with plaque psoriasis.

Interim analysis of the ongoing PSOARING 3 long-term safety study was conducted once at least 100 subjects had received tapinarof cream, 1% for 52 weeks, and an additional 300 subjects had received tapinarof cream, 1% for 26 weeks. Analysis revealed that 57 percent (298/520) of subjects who entered the study with a Physician Global Assessment (PGA) score ≥ 2 achieved a PGA score of 0 or 1, indicating increased therapeutic effect beyond the 12-week double blind treatment periods in PSOARING 1 and 2.

An integrated analysis of efficacy data from PSOARING 1, PSOARING 2 and the PSOARING 3 interim analysis determined that 57 percent of subjects had a PGA response of 0 (clear) or almost clear (1), plus at least a 2-grade improvement from baseline, at any time point. Sixty-three percent of subjects achieved PASI 75 at any time point, and 44 percent achieved PASI 90 at any time point.

No evidence of tachyphylaxis was observed, and no new AEs were identified.

“The achievement of a PGA score of 0 or 1 by 57.3 percent of patients following tapinarof treatment is impressive and will be important to patients and prescribers,” says Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine and lead investigator for the PSOARING 3 study, in a statement. “With nearly 40 percent of patients achieving complete disease clearance, tapinarof has the potential to be an important new topical treatment option for patients suffering from psoriasis.” 

“We are excited to share the results from our interim analysis of PSOARING 3, which represent yet another milestone for Dermavant as we progress towards a mid-2021 NDA submission for tapinarof in adult patients with psoriasis,” adds Todd Zavodnick, Chief Executive Officer of Dermavant, in a statement. “We are now focused on compiling a comprehensive NDA submission highlighting the treatment effect, durability on-therapy, remittive effect off-therapy, safety, and tolerability of tapinarof. At the same time, we are furthering our commercial readiness in anticipation of tapinarof’s potential approval, and advancing the other assets in our development pipeline.”