LONG BEACH, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced it will present data from its Phase 3 PSOARING trial program of VTAMA® (tapinarof) cream, 1% at the 31st European Academy of Dermatology and Venereology (EADV) Congress, to be held September 7-10 in Milan, Italy.
Following 25 years of minimal innovation in topical psoriasis treatments, this May, the U.S. Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of plaque psoriasis in adults. VTAMA cream is approved for mild, moderate and severe plaque psoriasis, with no label restrictions on duration of use or body surface area.
The following posters will be available on-site and online on the EADV Virtual platform at the start of the meeting Wednesday, September 7th, 2022. E-posters will be available on the virtual platform through November 30th, 2022.
Title: Treat-to-Target Outcomes and Measures of Treatment Success in Three Phase 3 Trials of Tapinarof Cream 1% Once Daily for Mild to Severe Plaque Psoriasis
This analysis examines the percentage of patients in the Phase 3 PSOARING trials who achieved percentage of body surface area affected of 1% or less and 0.5% or less and absolute Psoriasis Area and Severity Index scores of less than or equal to 1, 2 and 3 using tapinarof cream, 1%.
Authors: April W. Armstrong, M.D., M.P.H; Robert Bissonnette, M.D., FRCPC; Philip M. Brown, M.D., J.D.; Anna M. Tallman, Pharm.D.; Kim A. Papp, M.D., Ph.D., FRCPC
Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Improvements in Quality of Life and Clinical Efficacy in Two Pivotal Phase 3 Trials
This poster will report Dermatology Life Quality Index and local tolerability scores as assessed by both patients and investigators from PSOARING 1 and PSOARING 2.
Authors: Linda Stein Gold, M.D.; Christopher E. M. Griffiths OBE, M.D., FRCP; Anna M. Tallman, Pharm.D.; Philip M. Brown, M.D., J.D.; Mark G. Lebwohl, M.D.
For more information about VTAMA (tapinarof) cream, 1%, visit VTAMA.com.
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 fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Dermavant Sciences at 1‑8 DERMAVANT (1-833-762-8268).
Impacting approximately 8 million Americans and 125 million people worldwide, psoriasis is a complex autoimmune disease — meaning that the body’s immune system targets and attacks its own cells. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80 to 90% of people with psoriasis. In people with light skin, plaque psoriasis is characterized by raised, red or pink patches of skin with silvery-white scale. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scale. The scale can be itchy, painful and disfiguring.
Psoriasis can begin at any age, but typically appears around 15 to 25 years of age. The exact cause of psoriasis is not known, but risk factors and triggers may include genetics or a family history of psoriasis, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions. People with psoriasis are at an increased risk of developing other health conditions, including psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. In addition to physical symptoms, psoriasis can have a significant impact on a person’s quality of life and psychological health.
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 commercialized, late-stage, and early-development 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 is also developing VTAMA cream for the treatment of atopic dermatitis in adults and children and expects to release topline results from its Phase 3 clinical trials in the first half of calendar year 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential differentiated 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).
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