Multinational biopharmaceutical company UCB has announced that its phase 2b BE AGILE study has established a dose response, as well as statistically significant efficacy, for bimekizumab as a treatment for adults with ankylosing spondylitis, according to a press release.
“The phase 2b results with bimekizumab in ankylosing spondylitis are striking, particularly because a stringent primary efficacy endpoint was used,” Emmanuel Caeymaex, head of immunology and executive vice president at UCB, told Healio Rheumatology. “The ASAS40 rates seen with bimekizumab appear better than anti-TNF and IL-17A inhibitors that have been studied in AS, especially when we consider placebo response, inclusion criteria, treatment duration, and other factors in this phase 2b trial.”
According to UCB, despite recent progress in biologics, as many as 40% of patients with ankylosing spondylitis respond poorly to standard biologic treatments. The company said the BE AGILE study demonstrated that bimekizumab has significant potential as a treatment option for patients with ankylosing spondylitis.
Bimekizumab is a novel humanized monoclonal IgG1 antibody that neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes, the company said. IL-17A and IL-17F have overlapping pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues. It has not been approved by any regulatory authority worldwide.
BE AGILE is a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of bimekizumab in 303 patients with ankylosing spondylitis. Researchers designed it to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the treatment. According to UCB, participants underwent a 12-week double-blind treatment period, with a subsequent 36-week dose-blind treatment period.
The study’s primary efficacy variable was the percentage of patients with ankylosing spondylitis who achieved at least 40% improvement in symptoms, including as pain, physical function and inflammation at week 12. According to the researchers, bimekizumab achieved this clinical response threshold for a statistically significant greater number of patients than placebo across multiple doses. Further, bimekizumab was generally well tolerated and no unexpected safety signals were observed.
According to the company, the most common adverse event observed was the common cold.
These data follow a previous phase 2b study of bimekizumab among patients with moderate-to-severe psoriasis. In that study, dual neutralization of IL-17A and IL-17F with bimekizumab resulted in up to 60% of patients achieving complete skin clearance at week 12, the company said.
UCB is currently developing bimekizumab for the treatment of additional diseases, including psoriasis and psoriatic arthritis.
“We have also recently seen very positive Phase 2b results with bimekizumab in psoriasis and psoriatic arthritis,” Caeymaex said. “In developing bimekizumab, we tested the novel hypothesis that selectively neutralizing both IL-17A and IL-17F can deliver superior outcomes for patients with these diseases.
According to Caeymaex, “strong clinical results seen to date” indicate that bimekizumab shows potential to bring significant and differentiated value to patients across all three disease states
“We are pushing forward our Phase 3 clinical programs to rapidly bring this novel monoclonal antibody to patients,” Caeymaex said. – by Jason Laday
Disclosure: Caeymaex reports employment with UCB.