Phase 1 study revealed significant FEV1 improvements within 15 min of a single dose of IV rademikibart — an antibody targeting interleukin-4 receptor alpha.
RT’s Three Key Takeaways:
- Rapid Airway Improvement: Patients with asthma or COPD experienced FEV1 improvements of 200 mL or more as early as 15 minutes after receiving a single intravenous dose of rademikibart.
- Durable Lung Function Gains: Mean improvements in airway function ranging from 200 mL to 400 mL were maintained for 29 days in both patient cohorts following the initial administration.
- Novel Mechanism of Action: Clinical data suggests the antibody provides bronchodilation independently from its primary function of blocking the interleukin-4 receptor alpha pathway.
Connect Biopharma reported positive preliminary topline results from a Phase 1 clinical pharmacology study of intravenous (IV) rademikibart, an antibody targeting interleukin-4 receptor alpha (IL-4Rα), for patients with asthma and COPD, according to a news release.
The study evaluated a single 300 mg dose administered as a 2-minute IV push. Results indicated that the treatment produced rapid improvement in FEV1, with many patients experiencing airway function increases of 200 mL or more within 15 minutes of dosing.
“The preliminary results from our Phase 1 IV study of rademikibart highlight its potential to transform the treatment paradigm for acute exacerbations, where there have been no new medications in decades,” said Barry Quart, ceo and director of Connect Biopharma, in a news release.
The trial included adult patients with stable asthma and stable COPD randomized to receive either rademikibart or a placebo. Mean baseline FEV1 was 1.9 L for the asthma cohort and 1.55 L for the COPD cohort. In addition to the rapid onset, mean FEV1 improvements of approximately 200 to 400 mL were maintained through Day 29 in both groups.
According to the news release, the study provides clinical confirmation of preclinical observations that rademikibart has a unique effect on bronchodilation that appears to function independently from blocking IL-4Rα.
“Current standard of care relies on β-agonist bronchodilators and systemic steroids, but many patients could benefit from the rapid bronchodilation observed with IV rademikibart with the added benefit of directly addressing the underlying inflammatory drivers of disease,” said Michael Wechsler, professor and director of the Cohen Family Asthma Institute at National Jewish Health, in a news release. Wechsler added that he is not aware of any other biologic with similar rapid bronchodilator-like effects, particularly for COPD patients where the healthcare need is significant.
The company is currently recruiting for Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD, with topline data expected in mid-2026. Following these results, Connect Biopharma plans to meet with the Food and Drug Administration (FDA) to gain alignment on a Phase 3 program.
