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Positive Top-Line Results for BIMZELX[®]▼(bimekizumab) in Phase 3 Non-Radiographic Axial Spondyloarthritis Study

©UCB

Brussels, Belgium – 18th January 2022 – 07:00 CET – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced positive top-line interim analysis results showing that the Phase 3 BE MOBILE 1 study met the primary and all ranked secondary endpoints.1 BE MOBILE 1 is the first study to evaluate the efficacy and safety of BIMZELX® (bimekizumab) in adults with active non-radiographic axial spondyloarthritis (nr-axSpA).

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.1 ASAS40 measures improvements in disease across four different domains - patient global assessment of disease activity, spinal pain, physical function and inflammation.2 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.1

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“We’re excited to share top-line findings from the second Phase 3 study in our clinical program of bimekizumab in axSpA. These positive results, together with the previously reported top-line data from the BE MOBILE 2 study, support the clinical potential of bimekizumab to improve patient outcomes across the full spectrum of axSpA, including both nr-axSpA and ankylosing spondylitis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB.

“Today’s positive findings from the Phase 3 BE MOBILE 1 study provide clear evidence supporting bimekizumab in the treatment of nr-axSpA, and suggest that targeting IL-17F in addition to IL-17A may be a promising treatment approach for this painful, chronic rheumatic condition that often starts in young adulthood,” said Prof. Atul Deodhar, MD, MRCP, Professor of Medicine, Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, U.S.

In BE MOBILE 1, the safety profile of bimekizumab was consistent with safety data seen in previous studies with no new observed safety signals.1 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 study3 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.

*  ASAS40 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.2

About BE MOBILE 1

BE MOBILE 1 is a randomized, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).2 BE MOBILE is the first Phase 3 bimekizumab research programme to include patients from China in its study population. The 52-week study is ongoing with top-line interim analysis results presented above. For additional details on the study, visit BE MOBILE 1 on clinicaltrials.gov.

BE MOBILE 1 enrolled participants with active disease.2 Study participants had to have adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria, inflammatory back pain for at least three months and no definitive radiographic sacroiliitis confirmed by central reading.2 Patients needed to demonstrate objective signs of inflammation by elevated C-reactive protein (CRP) and/or positive magnetic resonance imaging (MRI). Study participants also had to have either failed to respond to two different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of four weeks or have had a history of intolerance to or a contraindication to NSAID therapy.2 Patients who had taken a tumor necrosis factor alpha (TNFα) inhibitor had to have experienced an inadequate response or intolerance to treatment.2

About Axial Spondyloarthritis

Non-radiographic axSpA (nr-axSpA) falls under the umbrella of axial spondyloarthritis (axSpA), which also includes ankylosing spondylitis, also known as radiographic axSpA.4 AxSpA is a painful chronic inflammatory disease that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).5 nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.4 The leading symptom of axSpA is inflammatory back pain that improves with exercise, but not with rest.4 Fatigue and stiffness are additional key symptoms. Other common clinical features frequently include acute anterior uveitis (eye inflammation), enthesitis (inflammation of the points of insertion of tendons and ligaments into bone), peripheral arthritis, psoriasis, inflammatory bowel disease (chronic inflammation of the digestive tract) and dactylitis (inflammation of the fingers or toes).4 The overall prevalence of axSpA is 0.2 percent to 1.4 percent of adults.6,7 Approximately half of all patients with axSpA are patients with nr-axSpA.4 Approximately two-thirds of patients with AS are men,8 while nr-axSpA is more common among women with the disease.8 AxSpA onset usually occurs before the age of 45, often in the 20s.4 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.4

About BIMZELX® (bimekizumab)

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.9  

In the European Union (EU)/European Economic Area (EEA) and in Great Britain, BIMZELX® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.10,11 Bimekizumab is not approved in psoriasis by any other regulatory authority outside the EU/EEA and Great Britain. Regulatory reviews are underway in Australia, Canada, Japan, Switzerland and the United States.

Bimzelx®▼(bimekizumab) EU/EEA Important Safety Information in Psoriasis

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%) (most frequently nasopharyngitis) and oral candidiasis (7.3%). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).

Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be administered in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB and patients receiving bimekizumab should be monitored for signs and symptoms of active TB.

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.

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