Eye on the AD Pipeline: Dermavant Completes Enrollment of Phase 3 Trials of VTAMA in Adults and Children with AD

Dermavant is developing VTAMA cream for AD using the same dose and regimen already FDA-approved for plaque psoriasis.

Dermavant Sciences has completed patient enrollment in its ADORING 1 and 2 Phase 3 clinical trials of VTAMA (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children as young as 2 years old.

VTAMA cream is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of AD. In the U.S., VTAMA cream is approved for the topical treatment of plaque psoriasis in adults – with no label safety warnings or precautions, restrictions on duration of use or body surface area. 

Dermavant is developing VTAMA cream for AD using the same dose and regimen already FDA-approved for plaque psoriasis.

“We are delighted to have completed enrollment in our ADORING 1 and 2 Phase 3 pivotal trials of VTAMA in atopic dermatitis, a chronic inflammatory skin condition with significant unmet medical need, especially in children,” says Todd Zavodnick, Chief Executive Officer of Dermavant, in a news release. “The potential expansion of our VTAMA franchise to include atopic dermatitis represents a major growth opportunity for Dermavant, as plaque psoriasis and atopic dermatitis represent the two largest markets in immuno-dermatology. We are excited about the potential for VTAMA cream to be a novel and highly differentiated treatment option for patients as young as 2 years old who suffer from atopic dermatitis. We’re encouraged by the progress we are making in our ADORING program and look forward to sharing the topline results from both Phase 3 studies in the first half of 2023.”

Dermavant recently published highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA cream in AD. The study demonstrated minimal-to-no systemic exposure despite maximal use. In addition, subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43%.

About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis

Dermavant’s pivotal Phase 3 clinical program for VTAMA (tapinarof) cream, 1% in atopic dermatitis consists of two identical pivotal trials (ADORING 1 and ADORING 2), followed by an open-label, long-term extension study (ADORING 3).

ADORING 1 and ADORING 2 are two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies being conducted in North America. The Phase 3 clinical program enrolled 813 patients across the two pivotal trials to evaluate the safety and efficacy of VTAMA cream, 1% dosed once daily (QD) for 8 weeks versus vehicle cream QD in patients aged 2 years and older diagnosed with moderate to severe AD. The primary endpoint of both clinical trials is the percentage of patients achieving a vIGA-AD™ (Validated Investigator Global Assessment for Atopic Dermatitis) of 0 or 1 with at least a 2-grade improvement from baseline at week 8.

ADORING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of VTAMA cream, 1% in patients with AD. The trial includes eligible patients who have completed treatment with VTAMA cream or vehicle in Phase 3 trials. ADORING 3 consists of up to 48 weeks with treatment of VTAMA cream, 1%, and a 7-day safety follow-up period.