Phase III PSOARING 1 and PSOARING 2 trials of GSK 2894512 meets primary endpoints in both trials for plaque psoriasis.- Dermavant Sciences

Dermavant Sciences announced positive results from phase III PSOARING 1 and PSOARING 2, two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of GSK 2894512 (tapinarof cream), 1% in adult patients with plaque psoriasis. In both PSOARING 1 (N=510) and PSOARING 2 (N=515), tapinarof cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement compared to vehicle from baseline at Week 12 (both P<0.0001), thus meeting the primary endpoint of each trial. additionally in both trials tapinarof cream demonstrated highly statistically significant improvement in pasi75 from baseline at week 12 both p><0.0001), a key secondary endpoint. in addition up to 80 of patients achieved a at least 1-grade improvement in pga across both studies. at week 12 35.4 and 40.2 of patients treated with tapinarof in psoaring 1 and psoaring 2 respectively achieved the primary endpoint of a pga score of clear 0 or almost clear 1 with a minimum 2-grade improvement compared to 6.0 and 6.3 of patients treated with vehicle p><0.0001; p><0.0001). also at week 12 36.1 and 47.6 of patients treated with tapinarof in psoaring 1 and psoaring 2 respectively achieved the key secondary endpoint of the proportion of subjects with at least 75 improvement in psoriasis area and severity index pasi compared to 10.2 and 6.9 of patients treated with vehicle p><0.0001; p><0.0001). the adverse event ae profile of tapinarof cream reported in both psoaring 1 and psoaring 2 was consistent with the ae profile observed in the previous phase iib trial with the majority of aes localized to site of application and mild to moderate in nature.>