First In Class:Benvimod's Phase 3 clinical psoriasis in overseas shift reaches the end point August 26, 2020,Dermavant Sciences announce,The company's fastest-growing product Tapinarof (DMVT-505) (1% cream formulation),Two multicenter, randomized, double-blind, blank matrix-controlled Phase 3 clinical trials named PSOARING 1 and PSOARING 2 for the indications of adult plaque psoriasis reached the primary endpoint.
Tapinarof is an investigational therapeutic aromatic receptor modulator (TAMA) that can be used to treat psoriasis and atopic dermatitis (AD). Tapinarof can regulate the activity of lymphocyte tyrosine kinases and aromatic hydrocarbon receptors, and inhibit the production of inflammatory cytokines in psoriasis, the infiltration of inflammatory cells, the abnormal proliferation of keratinocytes, and the formation and proliferation of blood vessels.
Specifically, in the phase 3 clinical trials named PSOARING 1 (N=510) and PSOARING 2 (N=515), compared with the blank control group, they received Tapinarof (DMVT-505) (1% cream formulation) ) (Used once a day) after 12 weeks of treatment, the treated patients have achieved a Physician Global Assessment (PGA) score of 0 (skin symptoms are completely cleared) or 1 (skin symptoms are almost completely cleared) and the score is the same as baseline The proportion of patients who improved by at least two levels was significantly higher than that of the control group, reaching the primary endpoint of the trial (P<0.0001)).
The key secondary clinical endpoint PASI75 (Psoriasis Area and Severity Index) (75% improvement in the Psoriasis Area Severity Index (PASI) score) also met expectations (P<0.0001).
Dermavant is expected to submit a new drug application (NDA) for this product to the US FDA in 2021.
2020 09/02