Positive top-line results for Bimzelx in phase III BE MOBILE 2 study to treat Ankylosing Spondyloarthritis.
BE MOBILE 2 is one of two Phase III studies evaluating bimekizumab across the full spectrum of axSpA disease, which includes both radiographic and non-radiographic (nr)-axSpA.
The BE MOBILE 2 study met its primary endpoint, as measured by the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16, when compared to placebo. ASAS40 measures improvements in disease across different domains, including patient global assessment of disease activity, spinal pain, physical function and inflammation. The primary endpoint used in this study, ASAS40, set a high threshold for improvement in patient-reported outcomes, i.e., at least a 40 percent improvement relative to baseline.
The study also met all ranked secondary endpoints, including significant improvements with bimekizumab over placebo at week 16 in patient-reported disease activity, as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); achievement of ASAS partial-remission (PR) and Ankylosing Spondylitis Disease Activity Score (ASDAS) Major Improvement (MI); and the nocturnal spinal pain score.
“Ankylosing spondylitis is a painful, chronic, inflammatory rheumatic disease that often starts in young adulthood. The encouraging top-line Phase III results are consistent with the Phase II findings and suggest that bimekizumab has the potential to deliver clinically meaningful improvements in the key signs and symptoms of the disease,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “Today’s findings for bimekizumab in ankylosing spondylitis follow closely behind the positive results in psoriatic arthritis reported last month and reinforce our continued commitment to advancing standards of care.”
Related news and insights
Novavax is awaiting US emergency use authorization for its prototype COVID-19 vaccine and is committed to bringing it to market. Clinical data generated to-date demonstrate that this prototype vaccine offers broad immune responses including against circulating variants, such as the Omicron BA.4/5.