Positive top-line results for Bimzelx in phase III non-radiographic axial spondyloarthritis study- UCB

In the BE MOBILE 1 study, bimekizumab demonstrated a statistically significant and clinically meaningful improvement over placebo in the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40 percent (ASAS40) response at week 16 the primary endpoint of the study. ASAS40 measures improvements in disease across four different domains - 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.

Patients treated with bimekizumab achieved significant improvements over placebo at week 16 in the signs and symptoms of disease 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.

In BE MOBILE 1, the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals. The safety and efficacy of bimekizumab in nr-axSpA have not been established. Bimekizumab is not approved for use in nr-axSpA or ankylosing spondylitis, also known as radiographic axSpA, by any regulatory authority worldwide. Results from the BE MOBILE 1 study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal.

The top-line results from the BE MOBILE 1 study build on the positive top-line results from the BE MOBILE 2 study in radiographic axSpA, reported in December 2021. Based on these results, UCB plans to submit regulatory applications for bimekizumab in axSpA in the United States and the European Union in Q3 2022.

ASA40 is achieved when there is at least a 40 percent improvement relative to baseline, and an absolute improvement of at least two units on a 0-10 numeric rating scale in at least three of the four domains that make up the ASAS response criteria – patient global assessment of disease activity, spinal pain, physical function and inflammation - with no worsening in the remaining domain.