Marching Towards FDA Approval: Dermavant's Vtama Cream Excels in Phase 3 Trial, Eyes 2024 Submission

Dermavant Sciences, a Roivant Sciences ROIV company, announced results from ADORING 1 Phase 3 trial of topical Vtama (tapinarof) cream, 1% in adults and pediatric subjects down to 2 years old with moderate to severe atopic dermatitis (AD).

ADORING 1 is the second of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical Vtama in adults and pediatric patients with atopic dermatitis.

In March, the company announced topline data from another Phase 3 trial, ADORING 2, demonstrating that Vtama met the trial's primary endpoint.

In ADORING 1 (N=407), 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 (P<0.0001).

At Week 8, 45.4% of subjects treated with Vtama achieved the primary endpoint.

55.8% of subjects treated with Vtama achieved ≥75% improvement in EASI.

55.8% of subjects 12 years and older receiving Vtama also experienced a statistically significant improvement in itch.

A supplemental marketing application to the FDA for Vtama in atopic dermatitis is anticipated to be filed in Q1 2024.

Price Action: ROIV shares are down 4.54% at $8.74 on the last check Tuesday.