August 26, 2020
– Primary Endpoints Met in PSOARING 1 and PSOARING 2 Clinical Trials (P-values <0.0001)
– Up to 80% of Patients Achieved ≥1-Grade Improvement in PGA
– All Secondary Endpoints Achieved in Both Trials, Including PASI75
– Tapinarof is a Potential First-in-Class Psoriasis Treatment with a Novel Mechanism of Action
– To Date, Over 2,200 Subjects Have Enrolled in 17 Clinical Trials of Tapinarof
LONG BEACH, Calif., and BASEL, Switzerland, August 26, 2020—Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from PSOARING 1 and PSOARING 2, two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream, 1% in adult patients with plaque psoriasis.
In both PSOARING 1 (N=510) and PSOARING 2 (N=515), tapinarof cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared to vehicle from baseline at Week 12 (both P<0.0001), thus meeting the primary endpoint of each trial. Additionally, in both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI75 from baseline at Week 12 (both P<0.0001), a key secondary endpoint. In addition, up to 80% of patients achieved a ≥1-grade improvement in PGA across both studies.
“We are very excited to announce the results from PSOARING 1 and PSOARING 2, which support the results observed in earlier trials. We believe these data give us a clear pathway to regulatory filing,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Subject to the completion and findings of our ongoing long-term extension study, which is fully enrolled, Dermavant currently expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for tapinarof topical cream for the treatment of plaque psoriasis in 2021. I am immensely proud of the progress Dermavant has made with the tapinarof Phase 3 program, and I would like to thank everyone involved in both of these important studies.”
“The PSOARING 1 and PSOARING 2 results support our belief that, subject to FDA approval, tapinarof cream could become a highly beneficial treatment option for adult patients living with mild, moderate and severe plaque psoriasis,” said Philip Brown, MD, JD, Chief Medical Officer of Dermavant. “With minimal systemic drug exposure, these data point to the potential use of tapinarof as a novel topical non-steroidal, capable of being used in sensitive and difficult to treat areas of the body such as face, groin and under arms. As such, we are excited by the efficacy and safety results of tapinarof exhibited across multiple trials.”
Tapinarof is a potential first-in-class, once-daily therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream being developed for the treatment of plaque psoriasis and atopic dermatitis.
Adult patients with plaque psoriasis (510 in PSOARING 1 and 515 in PSOARING 2) were randomized in a 2:1 ratio to receive once daily (QD) treatment with tapinarof cream, 1% or vehicle cream. At Week 12, 35.4% and 40.2% of patients treated with tapinarof in PSOARING 1 and PSOARING 2 respectively achieved the primary endpoint of a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared to 6.0% and 6.3% of patients treated with vehicle (P<0.0001; P<0.0001). Also at Week 12, 36.1% and 47.6% of patients treated with tapinarof in PSOARING 1 and PSOARING 2 respectively achieved the key secondary endpoint of the proportion of subjects with ≥75% improvement in Psoriasis Area and Severity Index (PASI) compared to 10.2% and 6.9% of patients treated with vehicle (P<0.0001; P<0.0001).
Table 1: PSOARING 1 and PSOARING 2 – Primary and Key Secondary Endpoint
|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|
The adverse event (AE) profile of tapinarof cream reported in both PSOARING 1 and PSOARING 2 was consistent with the AE profile observed in the previous Phase 2b trial, with the majority of AEs 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.
“Based on previously published data and my firsthand experience as an investigator, these highly statistically significant Phase 3 results point to tapinarof as an effective potential new treatment for psoriasis,” said Mark G. Lebwohl, MD, Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai, and the lead investigator for the PSOARING 1 study. “As a non-steroidal topical cream with the level of efficacy demonstrated in the PSOARING studies, and the potential versatility to be used across mild, moderate, and severe plaque psoriasis, including intertriginous and other sensitive skin areas, I believe tapinarof could become an important treatment for adult patients suffering from this skin disorder.”
“Plaque psoriasis remains a chronic disease for millions of patients globally, and can result in a profound burden on a patient’s quality of life if not adequately controlled,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, and lead investigator for the PSOARING 2 study. “Based on these Phase 3 trial results and subject to FDA approval, tapinarof could offer healthcare providers and patients a highly efficacious, well tolerated, non-steroidal first line treatment for psoriasis in a cosmetically elegant cream – long an aspiration for dermatologists.”
The data from this trial, including additional secondary endpoint data not covered in this release, will be submitted for presentation at an upcoming medical congress and to a peer-reviewed medical journal for publication.
Tapinarof previously met the primary endpoints in separate Phase 2b trials for plaque psoriasis and atopic dermatitis. Both studies were published in The Journal of the American Academy of Dermatology (JAAD), the official, peer-reviewed, scientific publication of the American Academy of Dermatology (AAD).
About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis
Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), an ongoing long-term (52-week) safety study.
The PSOARING studies, PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies that evaluated the efficacy and safety of tapinarof cream, 1% dosed QD for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
Following the 12-week, vehicle-controlled portion of PSOARING 1 and PSOARING 2, patients had the option to enroll in PSOARING 3, a separate, long term, open-label extension study for an additional 40 weeks of treatment. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in the long-term safety study.
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.
About 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 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).