Dermavant has submitted a New Drug Application (NDA) to the FDA seeking approval for its novel topical for the treatment of mild, moderate, and severe plaque psoriasis in adult patients.
Dermavant announced they have submitted a New Drug Application (NDA) to the FDA seeking approval for tapinarof cream for the treatment of mild, moderate, and severe plaque psoriasis in adult patients, according to a press release from the company.1
Tapinarof cream (GSK2894512, Dermavant), a novel once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA), which inhibits many of the proinflammatory mediators associated with inflammation and has been shown to enhance the skin barrier function.2 The topical is currently being evaluated for psoriasis and atopic dermatitis.
“Psoriasis impacts approximately 8 million Americans, who have to navigate the physical and emotional toll from this devastating disease,” said Todd Zavodnick, CEO of Dermavant. “Today’s NDA submission marks a significant milestone as we work toward FDA approval of tapinarof for adults with plaque psoriasis and their dermatologists who are looking to fill current treatment gaps. We plan on continuing our commercial preparations to bring this novel product candidate to the U.S. market as expeditiously as possible, subject to regulatory approval.”
The submission is supported by positive data from 2 phase 3, identical, multi-center, randomized, vehicle-controlled, double-blind clinical trials (PSOARING 1; NCT03956355 and PSOARING 2; NCT03983980), as well as positive interim data from an ongoing 40-week, open-label safety study (PSOARING 3; NCT04053387).
In PSOARING 1 and PSOARING 2, a total 1,025 combined patients received either tapinarof cream 1% once daily or vehicle once daily over the course of 12 weeks. Following the 12-week studies, patients were given the option to participate in an ongoing 52-week safety study, PSOARING 3.
Results of the studies show tapinarof met all primary and secondary endpoints, as well as demonstrated a similar safety profile consistent with previous trials.
In PSOARING 1, 35.4% of patients who received tapinarof 1% (n=340) achieved a Physician Global Assessment (PGA) score of 0 or 1 at week 12 compared with 6% who were treated with vehicle (n=170). Also, 36.1% of patients in the tapinarof group reached Psoriasis Area and Severity Index (PASI) score of 75 at week 12 vs 10.2% of those in the vehicle group.
In PSOARING 2, 40.2% of patients who received tapinarof once daily (n=343) achieved a PGA score of 0 or 1 at week 12 vs 6.3% of those treated with vehicle (n=172). Meanwhile, 47.6% of patients treated with tapinarof reached PASI 75 at week 12 compared with 6.9% of those treated with vehicle. The company also reports up to 80% of patients achieved a ≥1-grade improvement in PGA throughout both studies.3
“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, in a press release accouncing the initial results from the 2 studies.3 “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.”
Additionally, researchers saw promising interim data from the ongoing PSOARING 3 study.
Results of the interim analysis demonstrated the following efficacy data4:
Also, the interim analysis demonstrated the following safety data:
The NDA was officially submitted on May 26, 2021, and the FDA has 60 days to review and determine whether to accept the filing.