UCB’s Bimekizumab Abstract

UCB to present bimekizumab’s results from BE MOBILE 1 for non-radiographic axial spondyloarthritis (nr-axSpA), BE MOBILE 2 for ankylosing spondylitis (AS), and BE COMPLETE study for psoriatic arthritis (PsA).

This year, the EULAR (European Congress of Rheumatology) 2022 will be held virtually and onsite in Copenhagen, offering the first-ever hybrid congress experience. Among the plethora of presentations planned for EULAR 2022, we have chosen something of paramount importance.

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively and directly inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.

UCB will present data from the two Phase III studies, BE MOBILE 1 and BE MOBILE 2, evaluating bimekizumab in treating active nr-axSpA and AS. Along with this, data from the open-label extension of the Phase IIb BE AGILE study, in which bimekizumab showed maintenance of clinical responses over three years in patients with active AS, will also be presented at the EULAR this year.

In BE MOBILE 1 and BE MOBILE 2, patients treated with bimekizumab (160 mg every 4 weeks [Q4W]) achieved statistically significant and clinically meaningful improvements in the signs and symptoms of axSpA, as defined by the primary endpoint measure of Assessment of SpondyloArthritis International Society 40 (ASAS40) at Week 16 compared to placebo.  Response rates increased to Week 24, and rapid achievement of ASAS40 response was seen for patients switching from placebo to bimekizumab at Week 16. According to the results, 47.7% and 48.8% of bimekizumab-treated patients achieved ASAS40 in BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS) at Week 16, respectively.

For PsA, Bimekizumab is in Phase III clinical development to treat active psoriatic arthritis with a 24-week interim analysis from the BE OPTIMAL study and a 16-week analysis from the BE COMPLETE study to be presented at EULAR 2022.

BE COMPLETE is a Phase III study designed to evaluate the efficacy and safety of bimekizumab in tumor necrosis factor-alpha inhibitors (TNFi) experienced adults with active psoriatic arthritis. BE OPTIMAL is a Phase III trial to assess the safety and efficacy of bimekizumab in treating adult patients with active psoriatic arthritis, who are biologic disease-modifying anti-rheumatic drug naïve. Both studies met their primary endpoint of ACR50 at Week 16, and all ranked secondary endpoints compared with placebo with statistical significance. In BE COMPLETE, 43.4% of TNF-inadequate responder patients treated with bimekizumab achieved ACR50 according to the results whereas 43.9% of biologic naïve patients treated with bimekizumab achieved ACR50 at Week 16 in the BE OPTIMAL study.

Conclusion

Bimekizumab is the first humanized monoclonal IgG1 for ankylosing spondylitis. In the AS space, Pfizer’s Xeljanz (tofacitinib), Abbvie’s Rinvoq (upadacitinib), Eli Lilly’s Taltz (ixekizumab), and Bausch Health/Leo Pharma/Kyowa Kirin’s Siliq/Kyntheum/Lumicef (brodalumab) are the few of Bimekizumab’s competitors.

Siliq and Taltz are IL-17 inhibitors, and they are already approved for AS and nr-axSpA in different regions. Brodalumab is approved in Japan, whereas Taltz is approved in the US and EU.

Considering Bimekizumab’s positive Phase III results and its ability to exert simultaneous specific inhibition of IL-17A and IL-17 F, it is expected to give stiff competition to these already approved drugs in this segment.

Pfizer’s Xeljanz is also approved for AS in the US, and Abbvie’s Rinvoq was approved last month for AS by the US FDA. Hence, it is expected to capture the current AS therapeutics market share to a greater extent. Both Xelanjz and Rinvoq, have an oral route of administration which gives them some advantage over the subcutaneously administered drugs like bimekizumab. However, with its superior efficacy, bimekizumab is expected to compete with Xeljanz and other approved drugs. The interim results from BE MOBILE 1 and BE MOBILE 2 studies show that the dual inhibition of IL-17A and IL-17F with bimekizumab in patients with active AS resulted in rapid, clinically relevant improvements in efficacy outcomes.

For PsA, competitors of bimekizumab include IL-17 inhibitors like Cosentyx (secukinumab) and Taltz (ixekizumab), both of which are approved for this indication. TNF-alpha inhibitors approved for this indication include Cimzia, Enbrel, Humira, etc. The interim results from BE OPTIMAL and BE COMPLETE studies provide clear evidence supporting the potential of bimekizumab, a dual IL-17A, and IL-17F inhibitor, in treating active psoriatic arthritis, and if approved, it is expected to offer a tough competition in the current PsA market.

UCB expects to submit regulatory applications for bimekizumab in axial spondyloarthritis and psoriatic arthritis by the third quarter of this year, and hence, all the results from the trials mentioned above are of paramount significance in this context.

For more detailed analysis, visit: Ankylosing Spondylitis Market