Dermavant Sciences has reported positive top line results from a phase 3 trial of its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children as young as two years of age with 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 10% of adults 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.
Dermavent’s ADORING 2 trial met its primary endpoint, with 46.4% of Vtama-treated patients experiencing a significant improvement in an investigator assessment of lesions.
Benefits were also seen across key secondary endpoints, including 59.1% of patients experiencing improvements on the EASI test, which is used to measure the extent and severity of the condition.
Additionally, 52.8% of patients aged 12 years and older saw a reduction in itching.
Philip Brown, chief medical officer at Dermavant, said: “We are highly encouraged by the positive results from ADORING 2, which suggests Vtama cream can be a potentially important non-steroidal, topical treatment option for atopic dermatitis patients, including children as young as two years of age where we know there is a compelling need.”
Brown added that the company expects top-line results from its identically designed ADORING 1 trial in May this year.
This latest data supports positive results recently released by the company from a paediatric maximal usage pharmacokinetics (MUPK) study of Vtama cream in atopic dermatitis, which demonstrated minimal to no systemic exposure despite maximal use.
Linda Stein Gold, director of clinical research and the division head of dermatology at the Henry Ford Health System, said: “When one considers this phase 3 data alongside the recently reported MUPK atopic dermatitis study, which in treated patients demonstrated minimal to no systemic exposure despite heavy disease burden, Vtama cream is positioning itself to be a potential two-in-one first-line topical treatment for both atopic dermatitis and plaque psoriasis.”
With the US Food and Drug Administration’s approval of Vtama in May last year, the treatment became the first non-steroidal topical novel chemical entity launched for psoriasis in the US in more than 25 years.