Dosing Starts in Tapinarof AD Trials

Dermavant has announced it has dosed the first patient in its phase 3 trial evaluating tapinarof cream for the treatment of moderate to severe atopic dermatitis.

Dermavant Sciences announced the first patient has been dosed in its pivotal phase 3 trial, ADORING 1 (NCT05014568), a double-blind, vehicle-controlled study of tapinarof (DMVT-505; Dermavant) for the treatment of atopic dermatitis (AD).1 

Tapinarof is an investigation therapeutic aryl hydrocarbon receptor modulating agent (TAMA). It is in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and AD.

The FDA accepted a New Drug Application for a tapinarof cream (GSK2894512; Dermavant) for the treatment of plaque psoriasis in adult patients back in August.2 This was after positive data from 2 phase 3, identical, multi-center, randomized, vehicle-controlled, double-blind clinical trials (PSOARING 1; NCT03956355 and PSOARING 2; NCT03983980), as well as positive interim data from an ongoing 40-week, open-label safety study (PSOARING 3; NCT04053387).3

“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,” said Todd Zavodnick, CEO of Dermavant. “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.”

The phase 3 clinical trial program will consist of 2 identical trials (ADORING 1 and ADORING 2 (NCT05032859)) following by an open-label, long term extension study (ADORING 3).

The identical programs will enroll up to 800 patients across the 3 trials to evaluate the safety and efficacy of tapinarof cream 1% used once daily for 8 weeks versus vehicle cream once daily in patients 2 years or older diagnosed with moderate to severe AD. The primary endpoint of the studies is the percentage of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 with at least a 2-point improvement from baseline at week 8. 

ADORING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% in patients with AD. Patients in the study will include those who have previously completed treatment with tapinarof or vehicle in phase 3 studies and it will have up to 48 weeks of tapinarof cream, 1%, and a 7-day safety follow-up period.

Reference:

1. Dermavant announces first patient dosed in ADORING, its pivotal phase 3 clinical program for tapinarof for the topical treatment of atopic dermatitis – Dermavant. Published September 9, 2021. Accessed September 13, 2021. https://www.dermavant.com/dermavant-announces-first-patient-dosed-in-adoring/

2. FDA accepts NDA for tapinarof cream. Published August 10, 2021. Accessed September 13, 2021. https://www.healio.com/news/dermatology/20210810/fda-accepts-nda-for-tapinarof-cream

3. Tapinarof cream submitted for approval for treatment of plaque psoriasis. Dermatology Times. Accessed September 13, 2021. https://www.dermatologytimes.com/view/tapinarof-cream-submitted-for-approval-for-treatment-of-plaque-psoriasis