Today, Dermavant Sciences announced the latest data analysis of taping of emulsion in two key phases 3 clinical trials for the treatment of patients with psoriasis. The results of the trial showed that about one-fifth of patients reached the standard of more than 90% improvement in psoriasis area and severity index (PASI 90) after receiving tapinarof emulsion for 12 weeks. At the same time, the patient's pruritus and quality of life have also been improved. These data will be included in the new drug application for tapinarof emulsion, and the company expects to submit a new drug application to the US FDA in the middle of this year.
Psoriasis, also known as psoriasis, is a common chronic, autoimmune inflammatory skin disease. There are approximately 125 million people with psoriasis worldwide. For patients with more severe symptoms, psoriasis has a major impact on their quality of life.
Tapinarof emulsion is a once-daily aromatic hydrocarbon receptor modulator (TAMA) being developed by Dermavant Sciences for the treatment of plaque psoriasis and atopic dermatitis. Aromatic hydrocarbon receptors play an important role in regulating autoimmune responses. Tapinarof can inhibit IL-17-mediated inflammation by regulating the function of aromatic hydrocarbon receptors. It is worth mentioning that this innovative treatment was first approved for marketing in China in 2019, called benvitimod cream, and was included in the 2020 medical insurance drug catalog for the first time in December last year. Previously, Dermavant Sciences has announced that tapinarof emulsion has reached the primary endpoint in two phases 3 clinical trials PSOARING 1 and PSOARING 2 for the treatment of patients with psoriasis. The results reported today include important secondary efficacy endpoints and patient-reported outcome data.
▲The molecular structure of Tapinarof (photo source: Edgar181, Public domain, via Wikimedia Commons)
The results of the trial showed that 18.8% and 20.9% of the patients in PSOARING 1 and 20.9% of the PSOARING 1 and PSOARING 2 trials reached the PASI 90 standard, which was significantly higher than the baseline before treatment (1.6% and 2.5%, respectively). . Besides, using a pruritus assessment system called PP-NRS for testing, in the 12th week of treatment, the proportion of patients whose PP-NRS score improved at least 4 points in the PSOARING 1 and PSOARING 2 trials was 67.5% and 59.7%, respectively, which was significantly better than that. Patients receiving vector therapy (46.1% and 31.3%, respectively). The quality of life scores tested using the Dermatology Life Quality Index (DLQI) have also been significantly improved.
"Our key Phase 3 clinical trial results add to the evidence for the effectiveness of tapinarof emulsion and will bring important changes to patients and the doctors who treat them, " said Dr. Philip M. Brown, Chief Medical Officer of Dermavant Sciences. "Patients report results The consistent, statistically and clinically significant improvement in this field supports the use of tapinarof emulsion as a topical non-steroidal drug for the treatment of patients with psoriasis."
Reference materials:
[1] Dermavant to Showcase PASI90, Itch, and Quality of Life Data from Phase 3 Pivotal Trials for Tapinarof at AAD VMX 2021. Retrieved April 23, 2021, from https://www.dermavant.com/dermavant-to-showcase-pasi90 -itch-and-quality-of-life-data-from-phase-3-pivotal-trials-for-tapinarof-at-aad-vmx-2021/
Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on treatment plans, please go to a regular hospital for treatment.
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