Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adults with COPD and Type 2 Inflammation
Key Highlights
- ➤Treatment failure reduced 81% through Week 4 versus placebo (p=0.0122)
- ➤New moderate to severe COPD exacerbations reduced 85% through Week 4 (p=0.030)
- ➤New emergency visits and hospital admissions reduced 100% through Week 4 (p=0.0137)
- ➤Connect Biopharma (CNTB) plans FDA discussions on a Phase 3 program
- ➤Rademikibart showed lower adverse-event incidence than placebo and no new safety signals
Expert Statements
Barry Quart, Pharm.D., CEO and Director of Connect Biopharma
“Topline data from our Seabreeze STAT COPD trial for rademikibart provides overwhelming evidence of the potential benefit early treatment with rademikibart may provide to COPD patients experiencing an acute exacerbation.”
Barry Quart, Pharm.D., CEO and Director of Connect Biopharma
“2025 claims data indicate that COPD patients going to the emergency department (ED) due to an acute exacerbation generate approximately $6 billion in healthcare costs in the following 30 days due to return visits to the ED or hospital.”
Barry Quart, Pharm.D., CEO and Director of Connect Biopharma
“This study demonstrated that rademikibart completely eliminated those return visits while decreasing new moderate to severe COPD exacerbations by 85% compared to placebo.”
Barry Quart, Pharm.D., CEO and Director of Connect Biopharma
“These groundbreaking results provide a unique opportunity to differentiate rademikibart in COPD from all other approved biologics.”
Barry Quart, Pharm.D., CEO and Director of Connect Biopharma
“We plan to engage with the FDA as soon as feasible regarding a Phase 3 registrational development program for rademikibart as add-on treatment for COPD.”
Surya Bhatt, MD, Director of the University of Alabama at Birmingham, UAB Center for Lung Analytics and Imaging Research (CLAIR)
“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.”
Surya Bhatt, MD, Director of the University of Alabama at Birmingham, UAB Center for Lung Analytics and Imaging Research (CLAIR)
“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.”
Mario Castro, MD, MPH, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine
“One of the greatest challenges in COPD management is helping patients recover from an acute exacerbation and remain stable once they leave the hospital.”
Mario Castro, MD, MPH, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine
“The reductions in hospitalizations seen with rademikibart address a critical period when patients are at particularly high risk for worsening disease.”
Mario Castro, MD, MPH, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine at the University of Kansas School of Medicine
“By helping stabilize patients during the vulnerable post-exacerbation period, rademikibart has the potential to provide benefit in both acute and long-term disease management and meaningfully improve patient care.”
– Rademikibart significantly reduced the rate of treatment failure compared to placebo through one month by 81% (p=0.0122) –
– Rademikibart significantly reduced the rate of new moderate to severe COPD exacerbations through one month by 85% (p=0.030) –
Get started
Create a free account to read the full story.