Promising Data from Dermavant's Phase 2b Study of Tapinarof in Psoriasis

Patients treated with once daily tapinarof 1% demonstrated improvement in PASI75 as early as week 2, according to data published in The Journal of the American Academy of Dermatology (JAAD) and reported by drug developer Dermavant. Data come from the Phase 2b randomized clinical trial of tapinarof, a therapeutic aryl hydrocarbon receptor modulating agent (TAMA), for the treatment of plaque psoriasis.

PASI75 associated with tapinarof was statistically significant starting at Week 8 and was maintained for four weeks after treatment discontinuation (through Week 16) compared with vehicle.Similarly, PASI90 response also showed statistically significant efficacy at Week 12 and a maintenance of effect at Week 16 for tapinarof 1% compared with vehicle.

Total target lesion grading scores improved from Week 2 onwards with tapinarof cream compared with vehicle and were maintained for four weeks after treatment discontinuation (through Week 16) in all tapinarof treatment groups.

A significantly higher proportion (88%) of patients treated with tapinarof 1% reported very or moderately improved psoriasis symptoms and psoriasis-related pruritus (76%), compared with those receiving vehicle QD (35%) at Week 12. 

Overall, there was a greater reduction from baseline in mean weekly PSD scores in the tapinarof groups compared with the vehicle groups, demonstrating an effect on outcomes important to patients with psoriasis.

As previously reported in JAAD, most adverse events were mild or moderate. The most commonly reported adverse events were folliculitis, contact dermatitis, and headache.

“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, MD, PhD, Chief Scientific Officer of Dermavant. “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.