LONG BEACH, Calif., & BASEL, Switzerland,--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the first patient has been dosed in a Phase 3, double-blind, vehicle-controlled pivotal study of tapinarof for the treatment of atopic dermatitis (AD).
Tapinarof is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.
“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, Chief Executive Officer 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.”
“Atopic dermatitis remains an area of unmet medical need, particularly in children. As such, we are pleased to report the first patient dosed in our Phase 3 ADORING study, as we investigate the role tapinarof may have on advancing treatment for patients as young as 2 years-old with AD,” said Philip M. Brown, M.D., J.D., Chief Medical Officer of Dermavant. “We are excited about the potential of tapinarof and are eager to progress these studies.”
About Dermavant’s Phase 3 Program for Tapinarof in Atopic Dermatitis
Dermavant’s pivotal Phase 3 clinical program for tapinarof in atopic dermatitis (AD) will consist of two identical pivotal trials (ADORING 1 and ADORING 2) followed by an open-label, long-term extension study (ADORING 3).
ADORING 1 and ADORING 2 are two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies that will be conducted in North America. The Phase 3 clinical program will enroll up to 800 patients across the two pivotal trials to evaluate the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 8 weeks versus vehicle cream QD in patients aged 2 years and older diagnosed with moderate to severe AD. The primary endpoint of both studies will be the percentage of patients achieving a vIGA-AD™ (Validated Investigator Global Assessment for Atopic Dermatitis) of 0 or 1 with at least a 2-grade 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. Subjects in the study will include those who have previously completed treatment with tapinarof or vehicle in Phase 3 studies. ADORING 3 will consist of up to 48 weeks of tapinarof cream, 1%, and a 7-day safety follow-up period.
About Atopic Dermatitis
Atopic Dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting over 26 million people in the U.S. alone and up to 10% of adults worldwide.
AD occurs most frequently in children, affecting up to 30% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease.
About Dermavant
Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).