Positive Phase 3 Results for Dermavant's Tapinarof Cream for Plaque Psoriasis

Dermavant Sciences shared positive results from PSOARING 1 and PSOARING 2, two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% in adult patients with plaque psoriasis.

In both PSOARING 1 (N=510) and PSOARING 2 (N=515), tapinarof cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared to vehicle from baseline at Week 12 (both P<0.0001), thus meeting the primary endpoint of each trial. Additionally, in both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI75 from baseline at Week 12 (both P<0.0001), a key secondary endpoint. In addition, up to 80 percent of patients achieved a ≥1-grade improvement in PGA across both studies.

“Based on previously published data and my firsthand experience as an investigator, these highly statistically significant Phase 3 results point to tapinarof as an effective potential new treatment for psoriasis,” said Mark G. Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, and the lead investigator for the PSOARING 1 study. “As a non-steroidal topical cream with the level of efficacy demonstrated in the PSOARING studies, and the potential versatility to be used across mild, moderate, and severe plaque psoriasis, including intertriginous and other sensitive skin areas, I believe tapinarof could become an important treatment for adult patients suffering from this skin disorder.”

“Plaque psoriasis remains a chronic disease for millions of patients globally, and can result in a profound burden on a patient’s quality of life if not adequately controlled,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead investigator for the PSOARING 2 study. “Based on these Phase 3 trial results and subject to FDA approval, tapinarof could offer healthcare providers and patients a highly efficacious, well tolerated, non-steroidal first line treatment for psoriasis in a cosmetically elegant cream – long an aspiration for dermatologists.”Tapinarof is a potential first-in-class, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream being developed for the treatment of plaque psoriasis and atopic dermatitis.

Adult patients with plaque psoriasis (510 in PSOARING 1 and 515 in PSOARING 2) were randomized in a 2:1 ratio to receive once daily (QD) treatment with tapinarof cream 1% or vehicle cream. At Week 12, 35.4% and 40.2% of patients treated with tapinarof in PSOARING 1 and PSOARING 2 respectively achieved the primary endpoint of a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared to 6.0% and 6.3% of patients treated with vehicle (P<0.0001; P<0.0001). Also at Week 12, 36.1% and 47.6% of patients treated with tapinarof in PSOARING 1 and PSOARING 2 respectively achieved the key secondary endpoint of the proportion of subjects with ≥75% improvement in Psoriasis Area and Severity Index (PASI) compared to 10.2% and 6.9% of patients treated with vehicle (P<0.0001; P<0.0001).

The adverse event (AE) profile of tapinarof cream reported in both PSOARING 1 and PSOARING 2 was consistent with the AE profile observed in the previous Phase 2b trial, with the majority of AEs localized to site of application, and mild to moderate in nature. The most commonly reported AEs were folliculitis, nasopharyngitis, and contact dermatitis. The discontinuation rate due to AEs for the subset of patients on tapinarof across the studies was <5.8%. No drug-related serious adverse events (SAEs) were reported in either study.

The data from this trial, including additional secondary endpoint data not covered in this release, will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.

Tapinarof previously met the primary endpoints 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), the official, peer-reviewed, scientific publication of the American Academy of Dermatology (AAD).

“We are very excited to announce the results from PSOARING 1 and PSOARING 2, which support the results observed in earlier trials. We believe these data give us a clear pathway to regulatory filing,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Subject to the completion and findings of our ongoing long-term extension study, which is fully enrolled, Dermavant currently expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for tapinarof topical cream for the treatment of plaque psoriasis in 2021. I am immensely proud of the progress Dermavant has made with the tapinarof Phase 3 program, and I would like to thank everyone involved in both of these important studies.”

“The PSOARING 1 and PSOARING 2 results support our belief that, subject to FDA approval, tapinarof cream could become a highly beneficial treatment option for adult patients living with mild, moderate and severe plaque psoriasis,” said Philip Brown, MD, JD, Chief Medical Officer of Dermavant. “With minimal systemic drug exposure, these data point to the potential use of tapinarof as a novel topical non-steroidal, capable of being used in sensitive and difficult to treat areas of the body such as face, groin and under arms. As such, we are excited by the efficacy and safety results of tapinarof exhibited across multiple trials.”