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 the publication of secondary efficacy and patient-reported outcomes from the Phase 2b randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis in The Journal of the American Academy of Dermatology (JAAD), the peer-reviewed scientific publication of the American Academy of Dermatology (AAD)1. 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 ≥50%, ≥75%, and ≥90% improvement in the Psoriasis Area and Severity Index from baseline (PASI50, PASI75, PASI90), in addition to mean change in PGA scores and total target lesion grading scores. Patient-reported outcomes include change over time in daily Psoriasis Symptom Diary (PSD) scores and patient global impression of change in overall severity of psoriasis symptoms and pruritus (itch) symptoms from baseline to Week 12.
Highlights from the Secondary Efficacy and Patient-Reported Outcomes
Secondary Efficacy Outcomes:
- Tapinarof 1% QD (n=25) demonstrated improvement in PASI75 as early as Week 2, which was statistically significant starting at Week 8 and was maintained for four weeks after treatment discontinuation (through Week 16) compared with vehicle QD (n=20) (p<0.001 at Week 12).
- Similarly, the PASI90 response also showed statistically significant efficacy at Week 12 and a maintenance of effect at Week 16 for tapinarof 1% QD (n=25) compared with vehicle QD (n=20) (p=0.001 at Week 12).
- Total target lesion grading scores improved from Week 2 onwards with tapinarof cream (n=103) compared with vehicle (n=39) and were maintained for four weeks after treatment discontinuation (through Week 16) in all tapinarof treatment groups (p<0.001 for all at Week 12).
- A significantly higher proportion of patients treated with tapinarof 1% QD reported very or moderately improved psoriasis symptoms (88%) (p<0.001) and psoriasis-related pruritus (76%) (p=0.006) compared with those receiving vehicle QD (35%) at Week 12.
- Overall, there was a greater reduction from baseline in mean weekly PSD scores in the tapinarof groups compared with the vehicle groups, demonstrating an effect on outcomes important to patients with psoriasis.
As previously reported in JAAD2, most adverse events were mild or moderate. The most commonly reported adverse events were folliculitis, contact dermatitis, and headache.
“We are grateful to JAAD for sharing this further evidence of the clinical response and efficacy demonstrated by tapinarof in our Phase 2b study for psoriasis, as such outcomes are extremely valuable to patients and the physicians who treat them,” said David Rubenstein, M.D., Ph.D., Chief Scientific Officer of Dermavant. “We are currently evaluating tapinarof’s intriguing maintenance of effect in our Phase 3 PSOARING program, for which we expect to announce top-line results in the second half of 2020.”
About the Tapinarof Phase 2b Psoriasis Study
In the Phase 2b double-blind, vehicle-controlled, multicenter study, 227 adult patients aged 18-65 years diagnosed with mild, moderate or severe plaque psoriasis involving between 1% and 15% 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 psoriasis lesions either once daily (QD) or twice daily (BID) for 12 weeks with a 4-week follow-up.
The primary endpoint of the study (previously reported and published in JAAD) was a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.2
Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the U.S. and 125 million worldwide.
Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.
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).
- Stein Gold L, et al. (2020). A phase IIb, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. J Am Acad Dermatol. Advanced online publication. https://doi.org/10.1016/j.jaad.2020.04.181
- Robbins K, et al. Phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of plaque psoriasis. J Am Acad Dermatol. 2019;80:714-21.