Dermavant to Present New ADORING Data Including Treatment of Patients with Skin of Color from Phase 3 Trials of VTAMA® (tapinarof) Cream, 1% in Adults and Children 2 Years of Age and Older with Atopic Dermatitis at the 2024 AAD Annual Meeting

March 1, 2024 |

6 min read

Dermavant Sciences announced that new ADORING data including treatment of patients with skin of color from Phase 3 trials of VTAMA® cream, 1% in adults and children 2 years of age and older with atopic dermatitis will be presented at the 2024 American Academy of Dermatology Annual Meeting, to be held from March 8-12 in San Diego, California.

Four poster presentations, including two oral presentations, will highlight the clinical data for VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older

LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that new ADORING data including treatment of patients with skin of color from Phase 3 trials of VTAMA® (tapinarof) cream, 1% in adults and children 2 years of age and older with atopic dermatitis will be presented at the 2024 American Academy of Dermatology Annual Meeting, to be held from March 8-12 in San Diego, California.

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of atopic dermatitis (AD). VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S. and is the same strength and formulation being studied in the ADORING Phase 3 development program for AD.

The following posters will be viewable onsite at the San Diego Convention Center. In addition, two of the abstracts have been selected for oral presentations during the conference, which will take place in the Upper Level, Sails Pavilion, Poster Center 2.

Oral and Poster Presentations:

Title: Tapinarof Cream 1% Once Daily in Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis in Two Phase 3 Trials: Patient-reported Outcomes (Accepted as Oral Presentation)

Authors: Eric L. Simpson, Adelaide A. Hebert, Howard Sofen, John Browning, Philip M. Brown, Anna M. Tallman, Stephen C. Piscitelli, David S. Rubenstein

Oral Presentation Date/Time: Friday, March 8, 9:00 a.m. — 9:05 a.m. PT

Presenter: Eric Simpson, MD, MCR

This oral presentation will highlight patient-reported outcomes (PROs) including quality of life measures (DLQI, CDLQI, IDQOL) and assessment of AD symptoms (POEM), for adults and children with atopic dermatitis treated with tapinarof cream 1% once daily (QD), from the Phase 3 ADORING 1 (N=407) and ADORING 2 (N=406) pivotal trials.

Title: Tapinarof Cream 1% Once Daily: Interim Analysis of ADORING 3 Phase 3 Long-term Extension Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis (Accepted as Oral Presentation)

Authors: Robert Bissonnette, Linda Stein Gold, Leon Kircik, Lawrence F. Eichenfield, H. Chih-Ho Hong, Kim A. Papp, Anna M. Tallman, Stephen C. Piscitelli, David S. Rubenstein, Philip M. Brown, Jonathan I. Silverberg

Oral Presentation Date/Time: Friday, March 8, 11:45 a.m. — 11:50 a.m. PT

Presenter: Robert Bissonnette, MD

This oral presentation will include data on the baseline characteristics of patients enrolling in ADORING 3, the open-label, long-term extension trial assessing the safety and efficacy of tapinarof cream 1% once daily (QD) for up to 48-weeks in adults and children down to 2 years of age with AD.

Title: Tapinarof Cream 1% Once Daily is Efficacious for the Treatment of Moderate to Severe Atopic Dermatitis in Patients with Skin of Color Down to 2 Years of Age in Two Pivotal Phase 3 Trials

Authors: Andrew F. Alexis, Leon Kircik, Raj Chovatiya, Zakiya P. Rice, Tina Bhutani, Philip M. Brown, Stephen C. Piscitelli, David S. Rubenstein, Anna M. Tallman, April W. Armstrong

This poster will present data on the efficacy of tapinarof cream 1% once daily (QD), among patients by Fitzpatrick Skin Types and self-identified race, in ADORING 1 and ADORING 2, which are two pivotal Phase 3 trials in adults and children down to 2 years of age with atopic dermatitis. The data will include the proportion of patients who achieved a Validated Investigator Global Assessment for Atopic Dermatitis(vIGA-AD™)score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, as well as the proportion of subjects who achieved ≥75% Improvement in Eczema Area and Severity Index (EASI75) score at Week 8.

Title: Tapinarof Cream 1% Once Daily was Well Tolerated for the Treatment of Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis Across Two Pivotal Phase 3 Trials

Authors: Linda Stein Gold, James Del Rosso, Benjamin D. Ehst, Matthew J. Zirwas, Lawrence J. Green, Philip M. Brown, Anna M. Tallman, David S. Rubenstein, Stephen C. Piscitelli

This poster will present data on patient and investigator-assessed Local Tolerability Scale (LTS) scores, including in sensitive and intertriginous skin areas, from ADORING 1 and ADORING 2, two pivotal Phase 3 trials that evaluated the safety and efficacy of tapinarof cream, 1% once daily (QD) in adults and children with AD.

IMPORTANT SAFETY INFORMATION

Indication: VTAMA^® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information and Patient Information.

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects 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 20% 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 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 medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA^® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration.

For more information, please visit www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).