Dermavant Shares Positive Phase 4 Tapinarof Data For Intertriginous Plaque Psoriasis

Nancy/Adobe Stock

Dermavant recently shared¹ positive results stemming from its phase 4 clinical trial (DMVT-505-4001; NCT05680740) evaluating tapinarof (VTAMA) cream 1% in adult patients with intertriginous plaque psoriasis (iPsO), also known as inverse psoriasis.

Approximately 20% to 30% of individuals with plaque psoriasis have iPsO, which can be difficult to treat due to its location on the eyelids, underarms, groin, or other sensitive areas that may make patients more prone to experiencing adverse effects via steroidal topical therapies.

These results expand upon those of previous studies evaluating tapinarof in adult plaque psoriasis (PSOARING 1 and PSORARING 2), which found that 36% and 40% of adult patients achieved treatment success via the Physician Global Assessment (PGA). Compared to patients being treated with a placebo, these numbers were significantly higher.

These new results showed that 82.8% of adult patients, including 3 patients with genital involvement, achieved an iPGA score of 0 or 1 and a 2-grade improvement from baseline to week 12. The majority of patients (65.5%) achieved complete clearance at week 8. Efficacy was rapidly onset, with clearance achieved in as early as 2 weeks of treatment.

Improvements in itch were also rapidly onset, with improvements notable by as early as week 1. Over time, 50% of patients achieved a minimum 4-point improvement in Peak Pruritus-Numeric Rating Scale by week 4, and 75% achieved the same improvement metric by week 12.

Tapinarof was well-tolerated by patients and adverse reactions were consistent with those exhibited and reported in previous trials.

“We are thrilled to share the positive data from our Phase 4 clinical trial of VTAMA cream for the treatment of intertriginous plaque psoriasis in adult patients,” said Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant.¹ “The results demonstrate that VTAMA cream is efficacious, safe and well tolerated for the treatment of plaque psoriasis in sensitive intertriginous areas, which are consistent with and build upon results from our PSOARING Phase 3 pivotal clinical trials. This Phase 4 trial of VTAMA cream has demonstrated the ability to not only safely address the visible lesions, but also to improve the quality of life because the plaques improved.”

Reference

1. Dermavant Sciences. Dermavant Dermavant Presents Positive Results from Phase 4 Open Label Trial of VTAMA tapinarof Cream 1 for the Treatment of Intertriginous Plaque Psoriasis in Adults at 43rd Annual Fall Clinical Dermatology Conference Comments. October 20, 2023. Accessed October 20, 2023. https://www.dermavant.com/dermavant-presents-positive-results-from-phase-4-open-label-trial-of-vtama-tapinarof-cream-1-for-the-treatment-of-intertriginous-plaque-psoriasis-in-adults-at-43rd-annual-fall-clinical-dermat/