Dermavant Sciences has reported positive results from a phase 3 trial of its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children aged as young as two years with moderate to severe atopic dermatitis.
More commonly referred to as eczema, atopic dermatitis is one of the most common inflammatory skin diseases, affecting over 26 million people in the US alone and up to 30% of children worldwide.
The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, face and neck.
Dermavant’s ADORING 1 trial met its primary endpoint, with 45.4% of Vtama-treated patients experiencing improvements in an investigator assessment of lesions. This is compared to 13.9% of patients who received vehicle cream.
Benefits were also seen across key secondary endpoints, including 55.8% of patients experiencing improvements on the EASI test, which is used to measure the extent and severity of the condition, versus 22.9% in the vehicle cohort.
Additionally, 55.8% of patients aged 12 years and older saw a reduction in itching, compared to 34.2% receiving vehicle.
This latest data supports positive results from the identically designed ADORING 2 trial, which were released by the company in March.
Philip Brown, chief medical officer at Dermavant, said: “Subject to US Food and Drug Administration approval, we believe that the positive safety and efficacy profile of Vtama, combined with its treatment simplicity, has the potential to change the approach in the way patients are treated.”
The company also recently reported positive results from a paediatric maximal usage pharmacokinetics (MUPK) study of Vtama in atopic dermatitis, which demonstrated minimal to no systemic exposure despite maximal use.
Adelaide Hebert, professor and chief of paediatric dermatology at McGovern Medical School, and Children’s Memorial Hermann, said: “Given the increasing need for an effective and well-tolerated, non-steroidal topical treatment option for the paediatric population, the efficacy and safety data from ADORING 1 results are encouraging and, combined with the positive results from the MUPK study, Vtama appears to have the potential to bring relief to children suffering from this disease.”