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 it will present new positive data from its Phase 4, open-label trial of VTAMA (tapinarof) cream, 1% for intertriginous plaque psoriasis in adults (N=34) and data from multiple other studies of VTAMA cream at the 2023 Fall Clinical Dermatology Conference, to be held October 19-22 in Las Vegas, NV.
On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis - with no label safety warnings or precautions, restrictions on duration of use or body surface area. Dermavant is also developing VTAMA (tapinarof) cream, 1% for the topical treatment of atopic dermatitis in adults and children down to 2 years old.
The following posters will be viewable in-person in the exhibit hall area at the Wynn Hotel in Las Vegas.
Title: Efficacy of Tapinarof Cream 1% Once Daily for the Treatment of Mild to Severe Intertriginous Plaque Psoriasis
The poster will present data from the Phase 4, open-label trial that evaluated the efficacy and safety of VTAMA (tapinarof) cream, 1% for intertriginous plaque psoriasis in adults (N=34).
Authors: Howard Sofen, Stephen Tyring, Sandra Marchese Johnson, Scott Guenthner, Patrick Shannon, Philip M. Brown, Katherine Tillman, Nancy Fitzgerald, Anna M. Tallman
Title: Tapinarof Cream 1% Once Daily Improves Patient-reported Outcomes in the Treatment of Mild to Severe Intertriginous Plaque Psoriasis
This poster will include patient-reported outcomes for adults (N=34) with mild to severe plaque psoriasis in intertriginous areas treated with VTAMA (tapinarof) cream, 1% from the Phase 4, open-label trial.
Authors: Howard Sofen, Stephen Tyring, Sandra Marchese Johnson, Scott Guenthner, Patrick Shannon, Philip M. Brown, Katherine Tillman, Nancy Fitzgerald, Anna M. Tallman
Title: Early Real-World Description of Baseline Demographics and Clinical Characteristics of Patients with Plaque Psoriasis on Tapinarof Cream 1%
This poster will include data on baseline demographics, clinical and treatment-use characteristics of adult patients with plaque psoriasis started on VTAMA (tapinarof) cream, 1% in real world practice.
Authors: Janine Fournier, Aseel Bin Sawad, Erin Zwick, Mariola Vazquez, Doral Fredericks, Anna M. Tallman, Krithika Rajagopalan
Title: Tapinarof Cream 1% Once Daily for the Treatment of Extensive Atopic Dermatitis in Adolescents and Children: Outcomes from the 4-Week Maximal Usage Trial
This poster will present data from the Phase 2, open-label, 4-week maximal usage trial of tapinarof cream 1% QD, which assessed pharmacokinetics, safety and tolerability in adolescents and children with extensive moderate to severe atopic dermatitis.
Authors: Amy Paller, Adelaide Hebert, Philip M. Brown, Victoria Butners, Nancy Fitzgerald, Mercedes E. Gonzalez, Stephen C. Piscitelli
Title: Rapid and Early Onset of Itch Relief with Tapinarof Cream 1% Once Daily in Two Pivotal Phase 3 Trials in Adults and Children Down to Two Years of Age with Moderate to Severe Atopic Dermatitis
This poster will present data on the efficacy endpoints that evaluated itch relief of VTAMA® (tapinarof) cream, 1% once daily (QD) in ADORING 1 and ADORING 2, two pivotal Phase 3 trials, based on mean daily changes in Peak Pruritus-Numeric Rating Scale (PP-NRS) and mean weekly changes in PP-NRS score through Week 8.
Authors: Eric Simpson, Jonathan I. Silverberg, Robert Bissonnette, Linda Stein Gold, April Armstrong, Adelaide A. Hebert, Rocco T. Serrao, Jeannette R. Jakus, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli, Anna M. Tallman, Lawrence F. Eichenfield
Title: Tapinarof Cream 1% Once Daily: Significant Efficacy in the Treatment of Atopic Dermatitis in Two Pivotal Phase 3 Trials in Adults and Children Down to 2 Years of Age
This poster will present data on the safety and efficacy of VTAMA® (tapinarof) cream, 1% once daily (QD) in ADORING 1 and ADORING 2, two pivotal Phase 3 trials in patients 2 years and older, including proportion of patients who achieved Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) response at Week 8, ≥75% Improvement in Eczema Area and Severity Index (EASI75) score at Week 8, and ≥4-point reduction in Peak Pruritus-Numeric Rating Scale (PP-NRS) score in patients ≥12 years old at Week 8.
Authors: Jonathan I. Silverberg, Lawrence F. Eichenfield, Adelaide A. Hebert, Eric Simpson, Linda Stein Gold, Robert Bissonnette, Kim A. Papp, John Browning, Pearl Kwong, Neil J. Korman, Philip M. Brown, David S. Rubenstein, Stephen C. Piscitelli, Matthew C. Somerville, Anna M. Tallman, Leon Kircik
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, 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 Psoriasis
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 scales. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scales. The scales can be itchy, painful and disfiguring.
Psoriasis can begin at any age, but typically appears around 15 to 25 years of age and 50 to 60 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.
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 commercialized, late-stage and earlier-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 topical treatment of atopic dermatitis in adults and children and reported positive topline results from its ADORING 1 and ADORING 2 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 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).
© 2023 Dermavant Sciences, Inc. All Rights Reserved. VTAMA® is the registered trademark of Dermavant Sciences, GmbH. vIGA-AD™ is the trademark of Eli Lilly and Co.