New Phase 2b bimekizumab data showed the novel investigational molecule delivered improvements in disease activity and in important patient-reported outcomes, such as pain, fatigue, morning stiffness, function and quality of life for patients with ankylosing spondylitis. Improvements are hypothesized to be associated with bimekizumab’s mechanism of action, which potently and selectively neutralizes both IL-17A and IL-17F cytokines.
Brussels, Belgium – 14 June 2019 – UCB, a global biopharmaceutical company, announced new Phase 2b data on the company’s key pipeline molecule, bimekizumab – a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F cytokines – that showed improvements in a range of important health-related domains and general well-being for patients with active ankylosing spondylitis (AS). Results from this study, which evaluated multiple treatment doses, were shared for the first time today at the Annual European Congress of Rheumatology (EULAR 2019), in Madrid.
“AS is a chronic immune-mediated inflammatory disease primarily affecting the sacroiliac joints and spine that can severely impair patients’ lives. Bimekizumab, which selectively neutralizes both inflammatory cytokines IL-17A and IL-17F, has been shown to more potently suppress inflammation than targeting IL-17A alone in preclinical research. The new Week 12 data from the Phase 2b AS study suggest that bimekizumab may deliver results that improve disease activity and outcomes that are most important from the patient perspective, like pain, fatigue, stiffness, mobility, and function,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President, Immunology Patient Value Unit, UCB.
The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide. Bimekizumab is now in Phase 3 trials, where the safety and efficacy are being evaluated in AS, non-radiographic axial spondyloarthritis, psoriatic arthritis (PsA) and psoriasis.
Week 12 results from the Phase 2b trial showed that up to four-times the number of bimekizumab-treated patients achieved at least a 50% improvement in the key symptoms impacting patients with AS, including pain, fatigue, morning stiffness and function, compared to placebo. On the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scale, which measures symptoms including fatigue, pain and stiffness, BASDAI 50 responses were achieved in 23.7–47.5% of patients across the different bimekizumab treatment doses, compared to 11.9% for placebo. Bimekizumab-treated patients also reported a higher level of improvement in physical function (i.e. felt less restricted by their condition) and a better quality of life, in addition to an improvement in their overall disease activity, compared to placebo.2 Improvements were observed in all bimekizumab-treated patients, irrespective of the dose regimen.
The safety profile was consistent with previous bimekizumab studies in AS and PsA, with no new safety findings observed. The most frequent treatment emergent adverse events were nasopharyngitis and headache. The overall incidence of treatment emergent adverse events was similar for bimekizumab treated-patients compared to placebo.
