The New England Journal of Medicine has published results from its PSOARING 1 and PSOARING 2 pivotal trials for its investigational drug tapinarof topical cream, a novel, steroid-free, therapeutic aryl hydrocarbon receptor (AhR) modulating agent under development for the treatment of plaque psoriasis in adults.

PSOARING 1 and PSOARING 2 were identical double-blind, vehicle-controlled pivotal trials that enrolled 1,025 patients aged 18-75 years who had a Physician’s Global Assessment (PGA) baseline score of 2 (mild), 3 (moderate) or 4 (severe) and plaque psoriasis covering from 3-20% of their body surface area.

Following a screening period, eligible patients were randomly assigned in a 2:1 ratio to tapinarof cream 1% or vehicle cream once daily. Participants were stratifed at entry by baseline PGA score. Trial visits occurred at screening, baseline, and weeks 2, 4, 8 and 12 during the treatment period.

In August 2020, Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercialising innovative therapeutics in immuno-dermatology, reported that PSOARING 1 and PSOARING 2 met their primary efcacy endpoints, with tapinarof cream demonstrating a highly statistically signifcant improvement in proportion of patients achieving a PGA response – i.e., a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline – compared with vehicle at week 12.

The studies also met all secondary endpoints, including proportion of patients who achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) score (PASI75), the percentage of patients with a PGA score of 0 or 1, the mean change in the percent of total body-surface area afected, and percentage of patients who had an improvement of at least 90% in the PASI (PASI90), from baseline at week 12 with high statistical signifcance.