UCB biopharma’s experimental therapy bimekizumab (CDP-4940, UCB-4940) significantly improved ankylosing spondylitis (AS) symptoms after 12 weeks of treatment in the Phase 2b BE AGILE trial (NCT02963506).
Although no cure has been discovered yet for AS, disease symptoms can be lessened with drugs that decrease pain and inflammation. Non-steroidal anti-inflammatory drugs (NSAIDs) are often the first-line treatment for AS, but increasing doses can lead to serious side effects.
Several biological drugs designed to inhibit specific components of the immune system crucial for inflammation are being developed and tested. However, up to 40% of patients do not respond well to them. In fact, few therapeutic options are currently available for AS patients.
Bimekizumab is a new therapy that selectively targets and neutralizes both IL-17A and IL-17F proteins. These molecules are known to play key regulatory roles in chronic inflammatory disorders.
Previous preclinical studies have shown that the dual neutralization of both IL-17A and IL-17F provides a greater reduction of skin and joint inflammation compared to individual suppression.
Similar promising results were obtained from earlier clinical studies in psoriasis and psoriatic arthritis patients, making bimekizumab a potential treatment for immune-mediated inflammatory diseases.
The goal of the Phase 2b BE AGILE trial is to evaluate the safety, efficacy, pharmacokinetics (how the drug is absorbed and metabolized by the body), and pharmacodynamics (the drug’s dose-effect relationship) of bimekizumab compared with placebo treatment in patients with active AS.
The randomized, double-blind, placebo-controlled study enrolled 303 adult patients. These patients had a history of either inadequate response, intolerance, or contraindication to NSAIDs.
Participants were randomized into five dose regimens to receive bimekizumab or placebo every four weeks for 12 weeks.
The trial’s primary goal was to analyze patients’ response to treatment at week 12 through the ASAS40 test. This measure refers to the percentage of patients who had at least a 40% improvement in symptoms such as pain, inflammation, and physical function.
Results showed that up to 47% of patients receiving bimekizumab reached an ASAS40 response across multiple doses. This result was only achieved by 13% of patients in the placebo group.
“The results with bimekizumab are remarkable, especially because a stringent ASAS40 primary efficacy threshold was used. Our results showed that AS patients experienced rapid disease improvement, which can truly have a positive impact on patients’ lives,” Désirée van der Heijde, an MD and PhD, and professor of rheumatology at Leiden University Medical Center in the Netherlands, said in a press release.
“By specifically targeting both IL-17A and IL-17F, bimekizumab may halt the inflammation driving the symptoms in a disease like AS,” van der Heijde added.
Regarding safety, no unexpected adverse events were observed, and the most common adverse event reported was the common cold (nasopharyngitis).
The trial will continue to evaluate the maintenance of bimekizumab’s efficacy and safety for an additional 36 weeks.
Emmanuel Caeymaex, head of immunology and executive vice president at UCB, said the biopharma’s researchers are also developing bimekizumab to treat other diseases,including psoriasis and psoriatic arthritis.
“We believe bimekizumab will bring significant value to patients and are committed to rapidly advancing our Phase 3 clinical program,” Caeymaex said.