December 9, 2021
– PSOARING 1 and 2 met their primary efficacy endpoint and all secondary endpoints
– New published data from PSOARING 1 and 2 include patient-reported outcomes and onset of PGA response
– PSOARING 1 and 2 data were included in U.S. New Drug Application for tapinarof for plaque psoriasis
LONG BEACH, Calif., and BASEL, Switzerland, December 9, 2021—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that The New England Journal of Medicine has published results from its PSOARING 1 and PSOARING 2 pivotal trials for its investigational drug tapinarof topical cream, a novel, steroid-free, therapeutic aryl hydrocarbon receptor (AhR) modulating agent under development for the treatment of plaque psoriasis in adults.
“The efficacy seen across virtually all study endpoints, as well as patient-reported outcomes, underscores the potential that tapinarof could have for adult patients with plaque psoriasis and the dermatology community as a non-steroidal, once daily cream with a completely novel mechanism of action,” said study author and board-certified dermatologist Mark Lebwohl, MD, FAAD, Dean for Clinical Therapeutics and Waldman Professor and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York. “In addition, the treatment of atopic dermatitis with tapinarof is currently being evaluated in Dermavant’s ADORING trials, and the AhR target may have greater importance across a spectrum of diseases including outside of dermatology as we gain more insight.”
“I believe the publication of our PSOARING Phase 3 pivotal trial results in The New England Journal of Medicine supports the strength of the findings and tapinarof’s potential as a once-daily, steroid-free topical cream for adult patients with mild, moderate or severe plaque psoriasis,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “We are grateful to The New England Journal of Medicine for broadening awareness of tapinarof and the importance of AhR as an emerging molecular target among the medical community. Looking ahead, we plan to continue our discussions with the FDA as we prepare to bring tapinarof to patients in the U.S. in 2022, subject to FDA approval.”
PSOARING 1 and PSOARING 2 were identical double-blind, vehicle-controlled pivotal trials that enrolled 1,025 patients aged 18-75 years who had a Physician’s Global Assessment (PGA) baseline score of 2 (mild), 3 (moderate) or 4 (severe) and plaque psoriasis covering from 3% to 20% of their body surface area. Following a screening period, eligible patients were randomly assigned in a 2:1 ratio to tapinarof cream 1% or vehicle cream once daily. Participants were stratified at entry by baseline PGA score. Trial visits occurred at screening, baseline, and weeks 2, 4, 8 and 12 during the treatment period.
In August 2020, Dermavant reported that PSOARING 1 and PSOARING 2 met their primary efficacy endpoints, with tapinarof cream demonstrating a highly statistically significant improvement in proportion of patients achieving a PGA response – i.e., a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline – compared with vehicle at week 12.
The studies also met all secondary endpoints, including proportion of patients who achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) score (PASI75), the percentage of patients with a PGA score of 0 or 1, the mean change in the percent of total body-surface area affected, and percentage of patients who had an improvement of at least 90% in the PASI (PASI90), from baseline at week 12 with high statistical significance.
|PSOARING 1||PSOARING 2|
|Endpoint||Tapinarof 1% QD (n=340)||Vehicle QD (n=170)||P value||Tapinarof 1% QD (n=343)||Vehicle QD (n=172)||P value|
|PGA response1 at Week 12||35.4%||6.0%||<0.0001||40.2%||6.3%||<0.0001|
|PASI752 at Week 12||36.1%||10.2%||<0.0001||47.6%||6.9%||<0.0001|
|PASI903 at Week 12||18.8%||1.6%||=0.0005||20.9%||2.5%||<0.0001|
The majority of adverse events (AEs) in PSOARING 1 and PSOARING 2 were localized to site of application, and mild to moderate in nature. The most commonly reported AEs were folliculitis, nasopharyngitis, and contact dermatitis. The discontinuation rate due to AEs for the subset of patients on tapinarof across the studies was ≤5.8%. No drug-related serious adverse events (SAEs) were reported in either study.
Previously unpublished data appearing in the NEJM includes onset of efficacy as evidenced by PGA, and PASI response over time data as well as Patient-Reported Local Tolerability Scores.
The published manuscript titled “Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis,” is available online, and will appear in the December 9 issue of The New England Journal of Medicine.
Dr. Mark Lebwohl has been a paid consultant and investigator for Dermavant.
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 earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, 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 topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).