New psoriasis drug! The third phase III study of bimekizumab, a double effect inhibitor of IL-17A / 17F, was successful, and its efficacy was better than that of Humira

December 7, 2019 / BIOON / -- UCB, a Belgian pharmaceutical company, recently published the positive results of phase III clinical study be sure to evaluate the efficacy of bimekizumab, a new anti-inflammatory drug, in the treatment of adult patients with moderate to severe chronic plaque psoriasis This study is the third phase III study of bimekizumab in the treatment of psoriasis reported by the company since October this year It compares bimekizumab with the flagship product Humira (sumilar, generic name: adalimumab, adamumumab) The results show that the study has reached the main and secondary end points of the whole study UCB has planned to submit bimekizumab's application for the treatment of adult patients with moderate to severe plaque psoriasis to regulatory authorities in mid-2020 Bimekizumab is a unique molecule with dual action mechanism It can neutralize IL-17A and IL-17F simultaneously and selectively, which are two key cytokines driving the inflammatory process Be sure (nct03412747) is a randomized, double-blind, positive drug-controlled phase III study comparing the efficacy and safety of bimekizumab and Humira in the treatment of adult patients with moderate to severe plaque psoriasis The study included a 24 week positive drug control initial treatment period followed by a blind administration maintenance treatment period until week 56 A total of 478 patients were enrolled in the study Before screening, these patients had chronic plaque psoriasis for at least 6 months, with an affected body surface area of at least 10%, a PASI score of at least 12, and an IgA score of at least 3 The common primary end points of the study were pasi90 remission (defined as at least 90% improvement in psoriatic area and severity index) and IgA 0 / 1 remission (defined as complete or almost clear lesions with at least 2 improvement from baseline) at week 16 The results showed that the study reached a common primary end point: at week 16, the proportion of patients in bimekizumab group who achieved both pasi90 and IgA 0 / 1 remission was higher than that in Humira group At the critical secondary end point, at weeks 16 and 24 of the treatment, the proportion of patients in bimekizumab group who achieved complete removal of lesions (pasi100) was significantly higher than that in Humira group In addition, bimekizumab was statistically superior to Humira in achieving rapid response (defined as PASI75 response at week 4 of treatment) During the maintenance period of blind administration, bimekizumab maintained a high level of skin lesions clearance until the 56th week Continuous data evaluation showed that the safety of bimekizumab was consistent with previous clinical studies The complete data of be sure research will be released at the scientific conference in 2020 It is worth mentioning that be sure is the third phase III study that has reported positive results of bimekizumab since October The data continue to follow the positive results of the first two phase III studies be vid and be ready Professor Kristian Reich, lead researcher of be sure research and professor of ibendorf medical center, Hamburg University, Germany, said: "positive drug control test is a key way to inform us of clinical knowledge and decision-making of psoriasis The results of be sure study confirmed the superiority of bimekizumab in psoriasis compared with a widely used tumor necrosis factor inhibitor, and further proved the important role of selectively targeting IL-17A and IL-17F " Iris Loew Friedrich, director of drug development and chief medical officer of UCB, said: "the results of be sure study are consistent with the positive results of our recently reported be vivid and be ready studies UCB is committed to addressing critical unmet needs in the adult population of moderate to severe plaque psoriasis, especially complete removal of lesions Our phase III study shows that bimekizumab has the potential to make meaningful changes in these patients " Bimekizumab is a new humanized monoclonal IgG1 antibody, which can neutralize IL-17A and IL-17F effectively and selectively, which are two key cytokines driving the inflammatory process IL-17A and IL-17F have similar pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage in multiple tissues At present, bimekizumab is being evaluated for the treatment potential of plaque psoriasis, psoriatic arthritis (PSA), ankylosing spondylitis (as) and non radiologic axial spondylitis (NR axspa) It is expected to obtain the first top line results by the end of 2021 Previous early clinical studies of psoriasis and psoriatic arthritis have shown that bimekizumab's unique dual neutralization of IL-17A / IL-17F may provide a new targeted therapy for the treatment of immune-mediated inflammatory diseases Preclinical studies in disease-related cells have shown that neutralizing IL-17A and IL-17F at the same time can reduce skin and joint inflammation and pathological bone formation to a greater extent than inhibiting IL-17A alone Source of the original text: bimekizumab phase 3 photosynthesis study demonstrates superiority versus Humira