The company announced the results from its long-term extension study, highlighting improved efficacy outcomes, quality of life, and tolerability data.
Today, Dermavant Sciences, a clinical-stage biopharmaceutical company, announced results from the phase 3 PSOARING 3 long-term extension study, at the American Academy of Dermatology Association Annual Meeting, held March 25 to 29, in Boston, Massachusetts. The announcement highlights results demonstrating durable improvements across efficacy outcomes, quality of life (QOL), and tolerability with the use of tapinarof (Dermavant Sciences) cream 1% for plaque psoriasis in adults.1
“Plaque psoriasis is often a lifelong condition that can have a significant negative impact on many aspects of a patient’s life,” said April W. Armstrong, MD, MPH, a dermatologist with Keck Medicine of USC and professor of dermatology and associate dean for clinical research in dermatology at the Keck School of Medicine of USC. “Due to limitations in current psoriasis therapies, there is a strong need for new topical treatments for adults suffering with this condition. The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging. As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.”
Patients for the extension study were eligible after the completion of either PSOARING 1 or PSOARING 2, both 12-week pivotal studies examining the treatment of tapinarof in adults with plaque psoriasis.
PSOARING 3 added an additional 40 weeks to the original study’s timeframe and consisted of open-label intermittent treatment with tapinarof based on Physician Global Assessment (PGA) score, then a follow-up after 4 weeks post-treatment. Added with the time in the initial study, plus the extension, these patients received treatment for up to 52 weeks.
The company reported that continued improvements were observed in patient assessments beyond that of the original 12-week pivotal studies. Efficacy outcomes changed in the percentage of affected body surface area, and Psoriasis Area and Severity Index. Additionally, QOL changes were seen in PSOARING 3 including Dermatology Life Quality Index. Tolerability assessments of tolerability were patient-reported, and there was investigator assessments of irritation at drug application sites.
Investigators rated the irritation for the majority of patients as no irritation (score of 0). That score includes those who applied tapinarof to sensitive skin and intertriginous areas at all times points within the extension study timeframe.
“We are pleased to report data demonstrating continued improvements in efficacy and patient reported outcomes with use of tapinarof cream 1% once daily, beyond 12 weeks in adults with plaque psoriasis,” said Philip M. Brown, MD, JD, chief medical officer of Dermavant. “These data reinforce the potential tapinarof holds as a possible new treatment option for adults with mild, moderate and severe plaque psoriasis, subject to FDA approval.”
A prescription drug user fee act target action data has been assigned by the FDA for the second quarter of 2022.
1. Dermavant showcases new long-term durability and tolerability data from phase 3 psoaring 3 trial of tapinarof cream for adults with plaque psoriasis at the 2022 AAD annual meeting. Dermavant Sciences. Press release. Published March 25, 2022. Accessed March 25, 2022. https://www.dermavant.com/dermavant-showcases-new-data-from-phase-3-psoaring-at-the-2022-aad-annual-meeting/