Connect Biopharma has announced topline results from its global Phase II study evaluating rademikibart, a potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. 

The treatment was assessed as an add-on treatment for acute exacerbations in adult participants with chronic obstructive pulmonary disease (COPD) and type 2 inflammation. 

“Acute exacerbations continue to be a major driver of morbidity in COPD, and there remains a need for therapies that can improve outcomes following these events,” said Dr Surya Bhatt, Director of the University of Alabama at Birmingham, UAB Center for Lung Analytics and Imaging Research (CLAIR) in Birmingham, Alabama. “The reduction in COPD exacerbations is compelling, and the clinically meaningful increase in pulmonary function provides a very important improvement over standard-of-care and supports the potential for rademikibart to improve outcomes for COPD patients following an acute exacerbation and for chronic maintenance.” 

The Phase II Seabreeze STAT COPD study enrolled 159 participants globally with an eosinophil count of ≥300 cells/μL who have experienced an acute COPD exacerbation. 

The results showed that rademikibart significantly reduced the rate of treatment failure by 81% through Week 4 compared to placebo and significantly reduced the rate of new moderate to severe COPD exacerbations by 85% through Week 4 compared to placebo. 

It also reduced new visits to emergency departments and hospital admissions for new exacerbations by 100% through Week 4 and reduced the use of rescue inhalers from Week 2 through Week 7, as well as significantly improving COPD symptoms at Week 2. 

Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13).