Positive Data for Dermavant’s Tapinarof in Late-Stage Plaque Psoriasis Study

 

With “impressive” results, a robust safety profile, and indications of a potential remittive effect in hand, Dermavant Sciences is preparing to submit its topical cream, tapinarof, for Food and Drug Administration (FDA) regulatory approval mid-year as a new treatment for adults with plaque psoriasis and atopic dermatitis.

Today, the clinical-stage biopharmaceutical company, a subsidiary of Roivant Sciences, announced positive safety and efficacy results from a planned interim analysis of its PSOARING 3 safety study of tapinarof, a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent steroid-free cream.

Efficacy results matched those of the first two aptly named PSOARING pivotal Phase III trials, with 57% of patients enjoying a PGA response of 0 (or clear), or 1 (almost clear), plus a 2-grade improvement from baseline, measured at any point of the study. Additionally, 39.2% (299/763) achieved complete disease clearance. 

“The achievement of a PGA score of 0 or 1 by 57.3% of patients following tapinarof treatment is impressive and will be important to patients and prescribers,” said the study’s lead investigator, Dr. Bruce Strober, M.D., Ph.D., a clinical professor of Dermatology at Yale University School of Medicine. “With nearly 40% of patients achieving complete disease clearance, tapinarof has the potential to be an important new topical treatment option for patients suffering from psoriasis.”

In addition, Tapinarof boasted a strong safety profile, with just  5.8% of participants discontinuing the cream due to adverse events (AEs) – results consistent with the PSOARING 1 and PSOARING 2 trials. Adverse events were contained to the area of direct application, and as with the first two studies, no serious treatment-related AEs were reported.

The interim analysis is comprised of data collected after 100 participants were treated with tapinarof 1% for 52 weeks, and 300 more for 26 weeks.

Its potential remittive effects could hold even more value for long-term psoriasis suffers. For patients coming into the trial with a PGA score of 0 (n=78), median time to the disease worsening (defined as a PGA score of ≥2) after discontinuing treatment was approximately 115 days, or 4 months.

“Having deep clinical experience with tapinarof across five studies, its potential remittive effect has always been very intriguing to me, and is a unique aspect of this new chemical entity,” said Dr. Robert Bissonnette, M.D., FRCPC, Chief Executive Officer and Medical Director of Innovaderm Research, a leading dermatology contract research organization. “This interim analysis indicates the potential remittive effects of tapinarof which, if approved, could facilitate disease management for long-suffering psoriasis patients.”

Dermavant expects completion of the current safety study in the first half of 2021 and plans to submit a new drug application (NDA) to the FDA in mid-2021.