Dermavant Sciences has announced new positive results from a phase 3 trial of its Vtama (tapinarof) cream, 1% in adult and paediatric patients as young as two years with moderate-to-severe atopic dermatitis (AD).
Otherwise known as eczema, AD is an inflammatory skin disease that affects over 26 million people in the US and 20% of children globally. The condition causes the skin to become itchy, dry and cracked.
Previous results from the ADORING 1 and ADORING 2 trials showed that the efficacy of the Vtama cream continued to improve beyond the eight-week double blind treatment period across multiple endpoints, with a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of zero (clear) or one (almost clear) and a two-grade improvement from baseline in 73% of patients.
The ongoing ADORING 3 trial consisting of 728 patients, is a long-term extension study to evaluate the safety and efficacy of Vtama cream, 1% in patients with AD for up to 48 weeks of total treatment.
The interim analysis safety data of ADORING 3 demonstrated that Vtama cream, 1% was well-tolerated across all treatment areas, including sensitive skin and intertriginous locations, with over 51% of patients achieving complete disease clearance with a vIGA-AD score of zero.
The analysed data will be included in the company’s Supplemental New Drug Application submission to the US Food and Drug Administration (FDA) in the first quarter of this year.
Todd Zavodnick, chief executive officer, Dermavant, said: “The highly encouraging data reported today is a significant milestone for patients suffering with AD and their families.
“We look forward to making Vtama cream, 1% available as a potential treatment option for both adults and children suffering from AD as expeditiously as possible, subject to regulatory approval.”
“If approved for the treatment of AD, Vtama cream’s efficacy and safety profile combined with its rapid onset of itch reduction, the most common symptom of AD, could provide an important new treatment option for not only patients suffering from the disease but also for their caregivers and the healthcare professionals treating them,” said Eric Simpson, director, CLEAR Eczema Center at the Oregon Health and Science University.
The cream has already received approval from the FDA to treat adults with plaque psoriasis in the same strength and formulation that is currently being studied in the development programme for AD.