The non-steroidal topical cream benvitimod (Tapinarof) showed positive results in treating plaque psoriasis in two parallel phase 3 clinical trials, announced Dermavant Sciences.
The identical, multicentre, randomised, double-blind, studies -PSOARING 1 and PSOARING 2, evaluated the efficacy and safety of benvitimod 1% in 1,025 adult subjects with plaque psoriasis.
Patients were randomly assigned in a 2:1 ratio to receive once-daily benvitimod cream or vehicle cream.
At week 12, 35.4% of treated subjects in PSOARING 1 and 40.2% of treated subjects in PSOARING 2 had a Physician’s Global Assessment score of clear or almost clear, with at least a two-grade improvement, compared with 6% and 6.3% of subjects, respectively, in the control groups (both P < .0001).
In addition, 75% or more improvement in Psoriasis Area and Severity Index was recorded in 36.1% and 47.6% of patients in the treatment groups at week 12 compared with 10.2% and 6.9% in the vehicle groups (both P < .0001).
“These highly statistically significant phase 3 results point to benvitimod as an effective potential new treatment for psoriasis,” 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, said in a release.
Adverse events were consistent with those in the phase 2b trial and included folliculitis, nasopharyngitis and contact dermatitis. No serious adverse events related to benvitimod were reported, noted the researchers.