Dermavant Sciences, a subsidiary of Roivant Sciences (NASDAQ:ROIV), reported positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical VTAMA (tapinarof) cream, 1% in adults and pediatric subjects down to two years old, with moderate-to-severe atopic dermatitis (AD).
ADORING 1 enrolled 407 subjects as VTAMA met the primary endpoint of the trial and demonstrated highly statistically significant improvement in the Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at week 8.
In addition, VTAMA demonstrated highly statistically significant improvement in the proportion of subjects with a more than 75% improvement in the Eczema Area and Severity Index from baseline at week 8, a key secondary endpoint.
Subjects 12 years and older receiving VTAMA also experienced a statistically significant improvement in itch with a more than a 4-point reduction in the patient reported Peak Pruritus Numeric Rating Scale, another key secondary endpoint.
“Subject to FDA approval, we believe that the positive safety and efficacy profile of VTAMA, combined with its treatment simplicity, has the potential to change the approach in the way patients are treated,” Philip Brown, M.D., CMO of Dermavant, said in a statement.
In the U.S., VTAMA is approved for the topical treatment of plaque psoriasis in adults.