New psoriasis drug! The second phase III study of bimekizumab, a double effect inhibitor of IL-17A / 17F, was successful!

November 16, 2019 / BIOON / - UCB, a Belgian pharmaceutical company, recently published the positive results of phase III clinical study be ready to evaluate the efficacy of bimekizumab in the treatment of adult patients with moderate to severe chronic plaque psoriasis The study is the second of three phase III studies on bimekizumab that the company will report this year, with results showing that the study reached all primary and secondary endpoints 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 ready is a randomized, double-blind, placebo-controlled, 56 week, phase III study with a randomized withdrawal period after the initial treatment period to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with moderate to severe plaque psoriasis A total of 435 patients were enrolled in the study These patients had been suffering from chronic plaque psoriasis for at least 6 months before screening, with an affected body surface area of at least 10% and a PASI score of at least 12 The common primary end points of the study were pasi90 remission (at least 90% improvement in psoriatic area and severity index) and IgA 0 / 1 remission (investigator's overall assessment [IgA] scale score of 0 or 1, i.e complete or almost clear lesions) at week 16 of treatment The results showed that this randomized withdrawal study reached a common primary end point: at week 16, the proportion of patients in the bimekizumab group who achieved both pasi90 and IgA 0 / 1 remission was significantly higher than that in the placebo group At the critical secondary end point, at week 16, the proportion of patients in the bimekizumab treatment group who achieved complete removal of lesions (pasi100) was significantly higher than that in the placebo group In addition, bimekizumab was statistically superior to placebo in terms of reported reduction of pruritus / pain / desquamation, and scalp lesions clearance or near clearance (IGA) Bimekizumab was statistically superior to placebo in achieving rapid response (defined as PASI75 response at week 4 of treatment) In addition, after the first 16 weeks of remission, the rate of remission at week 56 was statistically higher with continued bimekizumab treatment than with placebo during the randomized withdrawal period of the study Preliminary data evaluation showed that the safety of bimekizumab was consistent with previous clinical studies The complete data of the be ready study will be released at the scientific conference in 2020, and these data comply with the positive results of the latest phase III be viviliv study report The be viviliv study evaluated the efficacy and safety of bimekizumab versus placebo and ustekinumab in the treatment of adult patients with moderate to severe plaque psoriasis The results showed that the study had all primary and secondary endpoints: at the 16th week of treatment, bimekizumab showed statistically significant advantages in skin lesions removal and disease improvement compared with placebo and ulinastamab Iris Loew Friedrich, director of drug development and chief medical officer of UCB, said: "we are pleased to release the positive data of bimekizumab for the second time in just four weeks The company is currently preparing to submit a listing application of bimekizumab to regulators in mid-2020 to provide this promising treatment scheme for psoriasis patients With the continuous success of our bimekizumab clinical project, the company will continue to implement the patient value strategy, linking the unmet needs of patients with innovative science " 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 its therapeutic potential in the treatment of plaque psoriasis, psoriatic arthritis (PSA), ankylosing spondylitis (as), and non radiologic axial spondylitis (NR axspa) 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: bimekizumab positive results confirmed in second phase 3 psoriasis study