Tapinarof shows promise in Plaque Psoriasis treatment in phase 3 trial results
Researchers have reported positive results with the use of Tapinarof cream (Dermavant Sciences), from 2 identical phase 3 studies.
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).
Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin.
Tapinarof is a novel aryl hydrocarbon receptor modulating agent (TAMA), for the treatment of plaque psoriasis in adult patients. The most commonly reported AEs were folliculitis, nasopharyngitis, and contact dermatitis.
With this as background, a group of researchers undertook the PSOARING 1 and PSOARING 2 studies. They were two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies undertaken to evaluate the efficacy and safety of tapinarof cream, 1% in adult patients with plaque psoriasis.
The study population collectively enrolled 1,025 patients, who were treated with 1% dosed QD for 12 weeks versus vehicle QD ,in adult patients aged 18-75 years diagnosed with plaque psoriasis. 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.
The primary endpoint of both studies was a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
Following the 12-week, a vehicle-controlled portion of PSOARING 1 and PSOARING 2, patients had the option to enroll in PSOARING 3, a separate, long term, open-label extension study for an additional 40 weeks of treatment. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in the long-term safety study.
Results of the trials showed that-
· 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 the 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 a highly statistically significant improvement in PASI75 from baseline at Week 12 (both P<0.0001), a key secondary endpoint.
· Also, up to 80% of patients achieved a ≥1-grade improvement in PGA across both studies.
"Based on previously published data and my firsthand experience as an investigator, this 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 the trials are ongoing, detailed results are being awaited for.
For the full article, click the link: https://www.businesswire.com/news/home/20200826005389/en/Dermavant-Reports-Positive-Phase-3-Results-Tapinarof.