Positive results were announced from 2 identical phase 3 studies evaluating tapinarof cream (Dermavant Sciences), a novel aryl hydrocarbon receptor modulating agent (TAMA), for the treatment of plaque psoriasis in adult patients.
The multicenter, randomized, double-blind, vehicle-controlled studies (PSOARING 1 [N=510] and PSOARING 2 [N=515]) assessed the efficacy and safety of tapinarof in 1025 patients aged 18 to 75 years with plaque psoriasis. Patients were randomized 2:1 to receive tapinarof cream 1% or vehicle once daily for 12 weeks. The primary end point for both studies was the proportion of patients with a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline to week 12.
Results from PSOARING 1 and 2 showed that 35.4% and 40.2% of patients treated with tapinarof, respectively, met the primary end point at week 12 compared with 6.0% and 6.3% for vehicle (both P <.0001). Moreover, the proportion of patients with ≥75% improvement in Psoriasis Area and Severity Index (PASI75; secondary end point) was 36.1% and 47.6% for tapinarof and 10.2% and 6.9% for vehicle in PSOARING 1 and 2, respectively (both P <.0001). Findings also showed that across both studies, up to 80% of patients treated with tapinarof achieved a ≥1 grade improvement in PGA.
As for safety, the majority of adverse events for tapinarof were localized to the site of application and were mild to moderate in nature. The most common adverse events included folliculitis, nasopharyngitis and contact dermatitis. No serious adverse events were reported.
Patients who completed the studies were eligible to enroll in an ongoing, open-label extension study (PSOARING 3) for an additional 40 weeks of treatment.
“We believe these data give us a clear pathway to regulatory filing,” said Todd Zavodnick, CEO 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 US Food and Drug Administration for tapinarof topical cream for the treatment of plaque psoriasis in 2021.”
The Company is also investigating tapinarof cream for the treatment of atopic dermatitis.
For more information visit dermavant.com.
Dermavant reports positive phase 3 results for tapinarof Cream in adult patients with plaque psoriasis. https://www.businesswire.com/news/home/20200826005389/en/Dermavant-Reports-Positive-Phase-3-Results-Tapinarof. Accessed August 26, 2020.