Rademikebart, a novel anti-interleukin-4 receptor alpha antibody developed by Connect Biopharma, demonstrated significant potential as an add-on treatment for acute COPD exacerbations in adults with type 2 inflammation.
- 85% reduction in moderate-to-severe COPD exacerbations through one month compared to placebo
- 100% reduction in hospitalizations and emergency department visits for acute COPD exacerbations
- 81% reduction in treatment failure rates, with improved pulmonary function at week two
- Well tolerated with no new safety signals
A novel add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation continues to show positive results in early trials.
Connect Biopharma is the manufacturer of rademikebart, an anti-interleukin-4 receptor alpha antibody. In a press release announcing preliminary results from its phase 2 trial, the company said the treatment significantly reduced the rate of new moderate-to-severe COPD exacerbations through one month by 85%.
The news comes after the company announced positive results in a phase 1 trial earlier in 2026.
Barry Quart, PharmD, CEO and director of Connect Biopharma, said data from the Seabreeze STAT COPD trial demonstrated that rademikebart also significantly reduced the rate of treatment failure compared to placebo through one month by 81% and the rate of hospitalizations or emergency department visits for new acute COPD exacerbations by 100%.
“These groundbreaking results provide a unique opportunity to differentiate rademikibart in COPD from all other approved biologics,” he said. “We plan to engage with the FDA as soon as feasible regarding a phase 3 registrational development program for rademikibart as an add-on treatment for COPD.”
The phase 2 Seabreeze STAT COPD study was a randomized, double-blind, placebo-controlled study with 159 participants who had an eosinophil count of more than 300 cells/μL and experienced an acute COPD exacerbation.
The primary endpoint was treatment failure, defined as death due to any cause, admission or readmission to a hospital for COPD, emergency department visit or revisit or unscheduled medical visit for worsening of COPD symptoms or the need to intensify pharmacologic treatment within 28 days after randomization.
In addition to the previous results, rademikibart also significantly reduced the use of rescue inhalers from week two through week seven and significantly improved COPD symptoms at week two compared to placebo. It was well tolerated with no new safety signals observed through the end of the study.
“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 Surya Bhatt, MD, director of the University of Alabama at Birmingham Center for Lung Analysis and Imaging Research. “The reduction in COPD exacerbations [in the trial] 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.”
