Injection therapy may cut rate, impact of severe COPD exacerbations
In global trial, single drug dose also seen to reduce type 2 inflammation
Written by |
A single injection of the next-generation drug rademikibart markedly cut the rate and impact of acute exacerbations among adults with chronic obstructive pulmonary disease (COPD) over one month versus a placebo in a global clinical trial.
That’s according to new data announced by therapy developer Connect Biopharma, which also showed that rademikibart reduced type 2 inflammation, characterized by high blood counts of eosinophils, a type of immune cell. Type 2 inflammation is thought to contribute to COPD-related lung inflammation.
Connect said the top-line data, or initial results, from the worldwide Phase 2 trial, called Seabreeze STAT COPD (NCT06940154), suggest that rademikibart is a “potentially best-in-class” treatment for the inflammatory disease, which is marked by cough with mucus, wheezing, and shortness of breath. The trial enrolled more than people with COPD experiencing an acute exacerbation requiring an urgent healthcare visit and showing high eosinophil counts.
“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, CEO and director at Connect, said in a company press release. “These groundbreaking results provide a unique opportunity to differentiate rademikibart in COPD from all other approved biologics.”
Biologics, such as rademikibart, are medications derived from living organisms.
The company now plans to engage with the U.S. Food and Drug Administration to gain alignment on a Phase 3 registrational trial testing rademikibart as an add-on treatment for COPD. This type of study is the final, large-scale stage of clinical testing designed to gather robust safety and efficacy data needed to secure regulatory approval in the U.S. for a new medical treatment.
COPD, a chronic inflammatory disease of the lungs, is marked by acute exacerbations, or a sudden worsening of symptoms, that may persist for several days.
“Acute exacerbations continue to be a major driver of [illness] in COPD, and there remains a need for therapies that can improve outcomes following these events,” said Surya Bhatt, MD, director of the UAB Center for Lung Analytics and Imaging Research at the University of Alabama at Birmingham.
Acute exacerbations in COPD generate about $6B in healthcare costs
According to Quart, “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.”
Rademikibart, administered by subcutaneous, or under-the-skin, injection, is designed to reduce the rate and impact of acute exacerbations in people with COPD.
The medication aims to block the action of interleukin-4 (IL-4) and IL-13, two proteins that drive type 2 inflammation. That is expected to cut the number of exacerbations among patients and also lessen their impact.
In Seabreeze STAT COPD, participants were randomly assigned to receive a single subcutaneous dose of either rademikibart (600 mg) or a placebo, in addition to standard care. The trial enrolled 159 people ages 40-80 who had lived with COPD for at least one year and experienced one or more exacerbations requiring the use of steroids.
The new data show that rademikibart significantly reduced the treatment failure rate by 81% compared with the placebo after one month, meeting the trial’s main goal.
Treatment failure rate was defined as death from any cause, a hospital readmission for COPD, an emergency department revisit or unscheduled medical visit for worsening COPD symptoms, or the need to intensify pharmacological treatment.
Rademikibart cut exacerbations by over 80% versus a placebo
Through week four, the one-time injection significantly reduced the rate of new moderate to severe COPD exacerbations by 85% relative to the placebo, the data show. Further, rademikibart completely prevented the occurrence of new emergency department visits and hospital admissions for new exacerbations, the developer noted.
“One of the greatest challenges in COPD management is helping patients recover from an acute exacerbation and remain stable once they leave the hospital,” said Mario Castro, MD, a professor at the University of Kansas School of Medicine. Castro also serves as chief of the university’s division of pulmonary, critical care, and sleep 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,” Castro said.
A single rademikibart injection also led to significantly greater reductions in rescue inhaler use from week 2 through week 7 and in COPD symptoms at week 2, compared with the placebo, the data showed.
One of the greatest challenges in COPD management is helping patients recover from an acute exacerbation and remain stable once they leave the hospital.
The developer noted that the treatment was also associated with improved lung function after one month, as assessed by forced expiratory volume in 1 second (FEV1), which is the amount of air a person can forcefully exhale in one second. FEV1 showed a 70 mL greater increase with rademikibart. While this difference did not reach statistical significance, the company said the change was clinically meaningful.
According to Bhatt, the “clinically meaningful increase in pulmonary function provides a very important improvement over standard-of-care.” Thus far, evidence from the trial “supports the potential for rademikibart to improve outcomes for COPD patients following an acute exacerbation and for chronic maintenance,” Bhatt said.
Regarding safety, rademikibart was well tolerated, with no new safety signals observed for up to two months. Adverse events and serious adverse events occurred at a lower rate in the rademikibart group than in the placebo group, the developer noted.
Leave a comment
Fill in the required fields to post. Your email address will not be published.