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Dermavant announces the enrollment completion for their two phase 3 clinical trials investigating the topical therapeutic aryl hydrocarbon receptor (TAMA) tapinarof as a treatment for adult plaque psoriasis, with results from the study still expected in the second half of 2020 despite the current pandemic.
Two phase 3 clinical trials for psoriasis will soon be underway following an announcement from Dermavant Sciences that they have completed patient enrollment for their PSOARING 1 and PSOARING 2 trials. Tapinarof is a once-daily therapeutic aryl hydrocarbon receptor (TAMA) 1% cream for adult plaque psoriasis.
The trials will be multi-center, randomized, identical, double-blind, parallel group studies that will investigate the safety and efficacy of tapinarof for treatment of plaque psoriasis in 1,025 adults over the course of 12 weeks with an optional 40-week independent open-label extension safety study available for patients to enroll in, according to a company press release.1
The primary endpoint is a proportion of patients who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at week 12.
“I’m excited to announce the completion of enrollment for our PSOARING Phase 3 clinical trials of tapinarof for the treatment of adult plaque psoriasis, one of the largest topical programs ever undertaken in this indication,” says Todd Zavodnick, CEO of Dermavant.
In the previous phase 2b trials published in The Journal of the American Academy of Dermatology, the company says tapinarof exhibited statistically significant responses in trials investigating the drug as a treatment for both atopic dermatitis and plaque psoriasis.1
“We believe tapinarof could be a highly differentiated psoriasis offering, potentially as the first topical with a novel mechanism of action in over 20 years, which makes today’s announcement an important milestone not just for the company, but for the psoriasis community as well,” says Zavodnick. “Tapinarof has now been dosed in over 1,700 subjects to date, and we believe it to be one of the most promising and cost-efficient therapeutics in dermatology today.”
Despite the current COVID-19 pandemic, Dermavant says the situation has not affected their studies, and fully expects results from both trials during the second half of 2020. If the studies’ results are positive, the company plans to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2021.
Additionally, Dermavant plans to continue enrollment of a long-term safety study for tapinarof and to begin their phase 3 clinical trials investigating the drug as a treatment for atopic dermatitis.
Dermavant Sciences. Dermavant Completes Patient Enrollment for Two Phase 3 Clinical Trials of Tapinarof for the Treatment of Psoriasis Comments. https://www.dermavant.com/dermavant-completes-patient-enrollment-for-two-phase-3-clinical-trials-of-tapinarof-for-the-treatment-of-psoriasis/. Published April 2, 2020. Accessed April 22, 2020.