Dermavant launches phase 3 trial of tapinarof for atopic dermatitis

A phase 3 trial of tapinarof cream for the treatment of atopic dermatitis has dosed its first patient, Dermavant Sciences announced in a press release.

The long-term, open-label ADORING 3 extension study will include up to 800 patients who have completed the ADORING 1 or ADORING 2 phase 2 trials and will study the safety and efficacy of tapinarof cream 1%, dosed daily for up to 48 weeks.

“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,” Todd Zavodnick, CEO of Dermavant, said in the release. “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.”

Tapinarof, an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, is in development for both atopic dermatitis and plaque psoriasis.