Tapinarof cream demonstrates positive phase 2b results

Tapinarof (GSK2894512, Dermavant), an investigative topical for the treatment of plaque psoriasis, demonstrated positive results in a phase 2b study recently published in the Journal of the American Academy of Dermatology (JAAD). Tapinarof 1% cream is a potential first-in-class topical with a novel mechanism of action, according to the company. Tapinarof inhibits many of the proinflammatory mediators associated with inflammation and has been shown to enhance the skin barrier function.¹

As reported in October by Dermatology Times, “It is an intriguing molecule,” says George Han, M.D., Ph.D. “If you look closely at the atopic dermatitis trials, the vast majority of patients who responded to treatment remained clear one month later. There are many reasons to believe that tapinarof will be helpful in more than one inflammatory skin condition due to its broad effect on pro-inflammatory cytokines.”¹

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The study was a randomized (1:1:1:1:1:1), phase 2b, double-blind, vehicle-controlled, multicenter clinical trial evaluating tapinarof 0.5%, 1% or vehicle in patients 18-65 years old with mild, moderate or severe plaque psoriasis that covered between 1% and 15% of their body surface area.

Researchers instructed subjects to apply the topical to their psoriasis lesions once daily (QD) or twice daily (BID) for 12 weeks, as well as a 4-week follow-up.

Results of the study demonstrate a Psoriasis Area and Severity Index (PASI) 75 improvement score as early as week two in tapinarof 1% QD (n=25) and statically significant by week eight, as well as maintained for four weeks post discontinuing treatment versus vehicle QD (n=20) (p<0.001 at week 12).²

Additionally, for tapinarof 1% QD (n=25) a PASI90 score was reported statistically significant at week 12 showcasing efficacy and maintenance through week 16 versus vehicle QD (n=20) (p=0.001 at week 12).

An improvement in total target lesion grading scores was reported at week two and further for all tapinarof (n=103) treatment arms and was maintained through week 16 compared to vehicle (n=39).

Patient-reported outcomes included a greater reduction from baseline in mean weekly Psoriasis Symptom Diary (PSD) scores for GSK2894512 treatment arms versus vehicle-treated arms. Also, at week 12, 88% of tapinarof 1% QD patients that reported moderately or very improved symptoms and psoriasis-related pruritis (76%) versus vehicle QD (35%).

The most common adverse events (AEs) were consistent as previously reported including mild-to-moderate contact dermatitis, headache and folliculitis.

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“We are grateful to JAAD for sharing this further evidence of the clinical response and efficacy demonstrated by tapinarof in our phase 2b study for psoriasis, as such outcomes are extremely valuable to patients and the physicians who treat them,” says David Rubenstein, M.D., Ph.D., chief scientific officer of Dermavant, in a company press release. “We are currently evaluating tapinarof’s intriguing maintenance of effect in our phase 3 PSOARING program, for which we expect to announce top-line results in the second half of 2020.”³

References:

1. Jesitus J. Nonsteroidal topical options expand. Dermatology Times. 40(10):17, 22.
2. Stein Gold L, et al. (2020). A phase IIb, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: Secondary efficacy and patient-reported outcomes. J Am Acad Dermatol. [published online ahead of print May 22, 2020]. doi:10.1016/j.jaad.2020.04.181.
3. Dermavant announces publication in JAAD of secondary efficacy and patient-reported outcomes in phase 2b clinical trial of tapinarof cream for the treatment of plaque psoriasis. Dermavant Sciences. https://www.dermavant.com/dermavant-announces-publication-in-jaad/. Published May 26, 2020. Accessed May 26, 2020.