Youshibi IL17-A/F double inhibitor reaches the end of phase 3 again and submits new drug application next year

Recently, UCB, a pharmaceutical company based in Brussels, Belgium, announced that bimekizumab, an IL-17A / F monoclonal antibody under development for the treatment of chronic moderate to severe plaque psoriasis, had reached two common primary endpoints and all secondary endpoints in the critical phase 3 trials It is expected that in mid-2020, youshibi will submit regulatory applications for bimekizumab Psoriasis is a common chronic, autoimmune inflammatory skin disease It is estimated that there are more than 7.5 million psoriasis patients in the United States, of which about 20% are moderate to severe plaque psoriasis Although symptoms vary from patient to patient, they may include red patches covered with silver scales, dry, chapped, bleeding, and thickened, sunken, or raised nails For patients with severe symptoms, psoriasis has a significant impact on their quality of life Despite advances in drug development in this area over the past decade, patient survey data show that patients with moderate to severe psoriasis do not receive adequate treatment When the levels of pro-inflammatory cytokines and anti-inflammatory cytokines are unbalanced, it will lead to the continuous occurrence of chronic inflammatory diseases such as psoriasis Based on IL-12, IL-23 / IL-17 signaling pathway plays a key role in the release of pro-inflammatory cytokines This signaling pathway has also become a hot target for pharmaceutical companies to treat chronic inflammatory diseases All humanized monoclonal antibody bimekizumab can neutralize IL-17A and IL-17F strongly and specifically IL-17A plays a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis and ankylosing spondylitis IL-17A and IL-17F have more than 50% structural homology and overlapping biological functions IL-17A and IL-17F are up-regulated in a variety of inflamed human tissues, and cooperate with other proinflammatory cytokines, such as tumor necrosis factor (TNF), to amplify the inflammatory response At the same time, by combining these two cytokines and preventing their interaction with IL-17 receptor expressed on the cell surface, bimekizumab can play a better role in anti-inflammatory ▲ working mechanism diagram of bimekizumab (picture source: reference [2]) A total of 435 patients participated in the 56 week be ready trial to verify the efficacy and safety of bimekizumab in the treatment of chronic moderate to severe plaque psoriasis (over 6 months of diagnosis, less than 10% of the affected area of the skin, Pai ≥ 12) compared with placebo The common primary end points of the trial were the proportion of patients who achieved PASI 90 remission (at least 90% improvement in PASI score of psoriatic area severity index) at week 16 and who achieved investigator's overall assessment (IGA) score of 0 or 1 (clearance or minimal disease), respectively Bimekizumab was statistically superior to placebo at all primary and secondary endpoints The specific test results of be ready will be announced at the medical conference in 2020 [1] Bimekizumab Positive Results Confirmed in Second Phase 3 Psoriasis Study Retrieved Nov 15, 2019, from https://www.prnewswire.com/news-releases/bimekizumab-positive-results-confirmed-in-second-phase-3-psoriasis-study-300958940.html [2] Bimekizumab Overview Retrieved Nov 15, 2019, from https://www.creativebiolabs.net/bimekizumab-overview.htm The original text has been deleted A kind of