LONG BEACH, Calif., and BASEL, Switzerland, June 16, 2020—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced the publication of secondary efficacy and patient-reported outcomes from its Phase 2b randomized clinical trial of tapinarof cream for the treatment of atopic dermatitis in The Journal of the American Academy of Dermatology (JAAD)1, the peer-reviewed scientific publication of the American Academy of Dermatology (AAD). Tapinarof cream is a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of plaque psoriasis and atopic dermatitis.
The latest analyses of the Phase 2b study published in JAAD include ≥75%, and ≥90% improvement in the Eczema Area and Severity Index from baseline (EASI75, EASI90), in addition to mean percentage change in EASI scores, the mean change in percentage of body surface area (BSA) affected, and mean change in total severity score.
Patient-reported outcomes include the proportion of patients who achieved ≥3-point improvement in pruritus (itch) numeric rating scale (NRS) score from baseline, subject impression of severity of atopic dermatitis symptoms, and subject impression of overall change in severity of itch symptoms from baseline to Week 12. The expanded Patient-Oriented Eczema Measure (POEM) was used to assess itch, sleep disturbance, and skin signs and symptoms, and the Daily Signs and Symptoms Severity Diary to score 11 disease-related symptoms.
Highlights from the Secondary Efficacy and Patient-Reported Outcomes
Secondary Efficacy Outcomes:
- Tapinarof 1% QD (51%; n=41) demonstrated statistically significant improvement in EASI75 compared to vehicle QD (25%; n=40) at Week 12 (p=0.016).
- Tapinarof 1% QD (-48%; n=41) demonstrated statistically significant greater reductions from baseline in mean percentage change in BSA compared to vehicle QD (-5%; N=40) at Week 12 (p=0.006), which was maintained for four weeks after treatment discontinuation (through Week 16) (p=0.038).
- More patients achieved ≥3-point improvement in pruritus NRS in the tapinarof groups (n=165) than the vehicle groups (n=82) from Week 2 onward.
- EASI90 response was statistically significantly higher in patients treated with tapinarof 1% QD (27%; n= 41) compared with vehicle QD (5%; n=40) at Week 12 (p=0.007).
Additional Patient-Reported Outcomes:
- Patients treated with tapinarof 1% QD (80%; n=41) demonstrated statistical significance in the rating of the overall severity of their atopic dermatitis symptoms as very or moderately improved compared with the vehicle QD (43%; n=40) at Week 12 (p<0.001).
- Patients treated with tapinarof 1% QD (78%; n=41) demonstrated statistical significance in the rating of the overall severity of their pruritus symptoms as very or moderately improved compared with the vehicle QD (40%; n=40) at Week 12 (p<0.001).
As previously reported in JAAD2, most adverse events were mild or moderate. The most commonly reported adverse events were nasopharyngitis, folliculitis, and atopic dermatitis.
“We are excited that JAAD has shared this additional evidence of tapinarof’s clinical response with these secondary efficacy and patient-reported outcomes from the Phase 2b study for atopic dermatitis,” said David Rubenstein, M.D., Ph.D., Chief Scientific Officer of Dermavant. “Because atopic dermatitis can interfere with daily life, these outcomes are especially important to patients, their caregivers, and the physicians who treat them. Dermatologists have shared with us their interest in potential topical treatment options that can address and relieve some of the very problematic symptoms of this debilitating skin disease, and today’s data speaks to the potential of tapinarof to meet this demand, subject to FDA approval.”
About the Tapinarof Phase 2b Atopic Dermatitis Study
In the Phase 2b double-blind, vehicle-controlled, multicenter study, 247 adolescent and adult patients aged 12-65 years diagnosed with mild to moderate atopic dermatitis involving between 5% and 35% body surface area were enrolled. Patients were randomized 1:1:1:1:1:1 to tapinarof cream 0.5%, tapinarof cream 1.0%, or vehicle, each applied to affected areas either once daily (QD) or twice daily (BID) for 12 weeks with a 4-week follow-up. In total, 165 patients were randomized to an active arm and 82 to vehicle.
The primary endpoint of the study (previously reported and published in JAAD) was an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.2
About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is a chronic inflammatory skin disease that results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. AD is one of the most common inflammatory skin diseases, affecting over 28 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.
People with AD are more likely to have other allergic conditions, like asthma, allergic rhinitis, and food allergies. 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.
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 early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, psoriasis and atopic dermatitis, as well as other large markets, including vitiligo, primary focal hyperhidrosis, and acne. Dermavant is developing its lead product candidate, tapinarof (DMVT-505), as a novel therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 28 million people in the United States, respectively. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
- Paller A, et al. (2020). Efficacy and patient-reported outcomes from a phase 2b, randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis. J Am Acad Dermatol. Advanced online publication. https://doi.org/10.1016/j.jaad.2020.05.135
- Peppers J, et al. A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2019;80:89-98.