Dermavant Sciences announced today that it dosed the first patient in a Phase 3 pivotal study of its atopic dermatitis (AD) treatment.
Long Beach, California-based Dermavant’s double-blind, vehicle-controlled pivotal study evaluates tapinarof for the treatment of AD, according to a news release.
The company developed tapinarof as an investigational novel, therapeutic aryl hydrocarbon receptor modulating agent as a once-daily, steroid-free and “cosmetically elegant” topical cream for treating inflammatory skin diseases such as plaque psoriasis and AD.
Dermavan’ts CMO Dr. Philip M. Brown said in the release that AD represents an area of unmet medical need, particularly in children, while the Adoring study investigates tapinarof as a treatment for patients as young as two years old.
“Atopic dermatitis is one of the most chronic inflammatory skin diseases, impacting more than 26 million people in the U.S. alone. The start of our Phase 3 program for tapinarof in atopic dermatitis represents a significant milestone for Dermavant, and follows quickly after the FDA’s acceptance of our NDA for tapinarof for the treatment of plaque psoriasis,” Dermavant CEO Todd Zavodnick said. “Our goal is to develop an atopic dermatitis treatment option that meets patient and dermatologist expectations for convenient and effective treatment. We intend to evaluate the results of the Adoring atopic dermatitis Phase 3 program with respect to five key attributes, which include treatment effect, durability on-therapy, remittive effect off-therapy, safety, and tolerability.”