The trials were identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies that evaluated tapinarof cream, 1% in adults with plaque psoriasis.
Dermavant Sciences, based in Long Beach, California and Basel, Switzerland, announced positive data from two Phase III clinical trials, PSOARING 1 and 2. The trials were identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies that evaluated tapinarof cream, 1% in adults with plaque psoriasis.
Psoriasis is a chronic, systemic, inflammatory skin disease. Symptoms include red patches and plaques with silvery scales on the skin. It affects about 8 million people in the U.S. and 125 million globally. Although it can start at any age, it generally has two peak starting points, at the age of 20 to 30 years and at the age of 50 to 60 years. Psoriasis patients are at increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression.
Tapinarof is a potential first-in-class, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream. It is also being developed for atopic dermatitis.
In addition to PSOARING 1 and 2, Dermavant’s tapinarof program includes an ongoing 52-week safety study. The two PSOARING studies enrolled 1,025 patients. They were dosed once-a-day for 12 weeks compared to vehicle once-a-day in adults aged 18 to 75 with plaque psoriasis. The primary endpoint of both trials was a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
After the 12-week, controlled portion of the trials, patients could enroll in PSOARING 3, a separate, long term, open-label extension trial for another 40 weeks. More than 90% of eligible patients who completed 1 and 2 enrolled in 3.
In addition to tapinarof demonstrating highly statistically significant improvement in the primary endpoint, the drug in both trials demonstrated highly statistically significant improvement in PAS175 from baseline at Week 12, which was a key secondary endpoint. Also, up to 80% of participants achieved an equal or greater than 1-grade improvement in PGA across both studies.
“We are very excited to announce the results from PSOARING 1 and PSOARING 2, which support the results observed in earlier trials,” said Todd Zavodnick, Dermavant’s chief executive officer. “We believe these data give us a clear pathway to regulatory filing. 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 III program, and I would like to thank everyone involved in both of these important studies.”
Dermavant is a subsidiary of Roivant Sciences, Vivek Ramaswamy’s umbrella company. Ramaswamy, 35, is a former hedge fund manager whose intention was to develop a new approach to biopharma development by investing in drugs that other companies had abandoned. The most notable was his company Axovant (all the companies have ‘vant’ in the name) acquired initepirdine for mild-to-moderate Alzheimer’s disease for $5 million from GlaxoSmithKline. Unfortunately, the drug failed in 2017 in a narrowly focused Alzheimer’s trial. Since, Ramaswamy’s approach has appeared to be more focused and traditional, with quite a number of successes.
In November 2019, Roivant sold five of its Vant companies to Japan’s Sumitomo Dainippon Pharma for $3 billion. Sumitomo Dainippon also acquired an equity stake of more than 10% of Roivant shares. That deal also included an option on six more Vant companies until 2024. Sumitomo Dainippon created Sumitovant Biopharma as an umbrella for the five companies, Myovant, Urovant, Enzyvant, Altavant and Spirovant, which are run by Myrtle Potter.
The deal also gave Sumitomo access to Roivant’s proprietary technology platforms, DrugOme and Digital Innovation. It also entered separate strategic client relationships with Datavant and Alyvant.
Linda Stein Gold, director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead investigator for the PSOARING 2 study, of today’s announcement, said, “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. Based on these Phase III 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.”
