Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD).
On Thursday, the company released results from a third phase 3 trial that bolster its case for approval in AD (eczema), which would triple the med's eligible patient population. In an interim analysis of the ADORING 3 open-label, long-term extension study of 728 patients who used Vtama for 48 weeks, 51% achieved complete disease clearance.
Additionally, in an integrated analysis of 711 patients from three ADORING studies, 81% achieved at least a 75% reduction in disease burden. In the same patient group, 73% had a validated investigator global assessment (vIGA)-AD score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement from baseline, the company said. In the vIGA-AD grading system, a score of 3 is moderate AD and 4 is severe.
In ADORING 3, when patients achieved complete clearance, treatment was withdrawn and they were able to maintain extended periods of flare-free days, according to Dermavant. This “remittive effect” could allow patients to “have control over their disease on a long-term basis without the need for daily or intermittent use of Vtama,” Philip Brown, M.D., Dermavant’s chief medical officer, said in a release.
The company plans to submit for FDA approval in AD in the first quarter of this year.
Vtama is a novel, aryl hydrocarbon receptor agonist. It was approved for plaque psoriasis in adults in May of 2022. In the three ADORING trials, the approved 1% dosage formulation was studied.
Additionally, the ADORING studies included patients as young as age 2, which is important considering that eczema occurs most frequently in children, Dermavant says.
Sales of Vtama scaled slowly last year—from $13.7 million (Q1) to $16.7 million (Q2) to $18.4 million (Q3)—compelling some analysts to temper their blockbuster expectations. But Dermavant’s CEO is confident that Vtama will fulfill its potential.
“It’s not a matter of if, it’s when,” Dermavant CEO Todd Zavodnick told Fierce Pharma in November. “Psoriasis got us to the dance and AD is gonna allow us to unlock the blockbuster, game-changing status.”