Dermavant Sciences (Dermavant) has shared positive results from its paediatric maximal usage study of Vtama (tapinarof) cream, in children aged from two to 17 years old with atopic dermatitis (AD).
The open-label trial enrolled 36 patients between the ages of two to 17 years and showed that Vtama offers favourable safety and clinical improvement for children in this age group with AD. There was a low incidence of adverse events and, even when applied to areas of sensitive skin, Vtama was well tolerated.
The study used the same dose and frequency as Dermavant’s ongoing ADORING 1 and ADORING 2 pivotal trials for AD. In May, the US Food and Drug Administration (FDA) approved Vtama at same dose and frequency to treat adults with plaque psoriasis.
The data will be added to Dermavant’s expected supplemental new drug application for AD, which will also include results from the company’s ongoing ADORING 1, 2, and 3 phase 3 studies for those aged two years and older.
AD, more commonly known as eczema, is one of the most common inflammatory skin diseases, and occurs most frequently in children, affecting up to 30% globally.
Philip Brown, chief medical officer of Dermavant, said: “We are delighted with the results from our maximal usage study of VTAMA cream, 1% in AD, which for the first time demonstrated highly favourable safety, pharmacokinetics, and clinical improvement in paediatric patients as young as two years of age.
“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 AD patients.”
Dermavant expects to announce the top-line results from ADORING 1 and ADORING 2 in the first half of 2023.