Positive Results for Dermavant's Vtama in Pediatric Maximal Usage Study in Atopic Dermatitis

11/09/2022

Dermavant Sciences shared positive results from its maximal usage study of Vtama (tapinarof) cream 1% in children down to age 2 years old with extensive burden of atopic dermatitis.

“We are delighted with the results from our maximal usage study of Vtama cream 1% in atopic dermatitis, which for the first time demonstrated highly favorable safety, pharmacokinetics, and clinical improvement in pediatric patients as young as two years of age,” says Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant, in a news release. “Despite maximal use conditions, in patients with up to 90% body surface area affected, we observed minimal to no systemic exposure, a low incidence of adverse events, and an overall excellent safety profile. In addition, these encouraging results were demonstrated in spite of the skin barrier defect common in atopic dermatitis patients.”

The open label maximal usage study enrolled 36 patients aged 2-17 years old, with an IGA ≥ 3 at screening (mean BSA of 43%, range of 26-90%), for four weeks of treatment with Vtama cream, 1% QD. The study’s objective was to characterize the pharmacokinetics (PK) and safety of Vtama cream under maximal usage conditions in pediatric subjects with atopic dermatitis. The maximal usage study of Vtama cream, 1% utilized the same dose and frequency (1% cream, applied QD) as is being studied in Dermavant’s ongoing ADORING 1 and ADORING 2 pivotal trials for atopic dermatitis. The same dose and frequency for Vtama cream, 1% has also been approved by the FDA for the topical treatment of adult plaque psoriasis.

Vtama cream, 1% demonstrated favorable safety, PK and clinical improvement in atopic dermatitis in subjects down to 2 years of age. There was a low incidence of adverse events (AEs) and Vtama cream 1% was well tolerated, even in sensitive skin areas. Minimal to no systemic exposure was confirmed under maximal use conditions in subjects with up to 90% body surface area (BSA) affected.

These maximal usage pharmacokinetics (MUPK) data will support Dermavant’s anticipated sNDA for atopic dermatitis which will also include results from the company’s ongoing ADORING 1, 2, and 3 phase 3 studies, in subjects aged 2 years old and above. Dermavant believes that having the same 1% topical cream drug product and dosing regimen in the pediatric population will be a key differentiator versus competing programs. The company anticipates announcing topline results from ADORING 1 and ADORING 2 in the first half of 2023.

The company says it anticipates presenting the full data set from its maximal usage study of Vtama cream 1% in atopic dermatitis at a future medical meeting.

The FDA  approved Vtama (tapinarof) cream 1% for the treatment of adult plaque psoriasis in May. The approval made Vtama cream 1% the first topical novel chemical entity launched for psoriasis in the US in more than 25 years. Vtama  is approved for mild, moderate, and severe plaque psoriasis with no label restrictions on duration of use or body surface area. Vtama cream showed a median remittive “off-treatment” effect of approximately 4 months with durability of response with no evidence of tachyphylaxis (loss of response) while on therapy, as demonstrated for up to 52 weeks in clinical studies. As of July 15, Vtama cream is the number one prescribed branded topical treatment for plaque psoriasis, the company reports.

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