A potential new treatment for COPD and asthma has taken another step on the road toward becoming available to the public. Connect Biopharma announced that the U.S. Food and Drug Administration (FDA) has approved its plans for two parallel phase 2 trials to evaluate rademikibart for moderate-to-severe COPD and asthma patients experiencing acute exacerbations.
Barry Quart, PharmD, CEO and director of Connect Biopharma, said in a news release that this in an area where no biologic therapies have been approved or systematically studied.
“During our Type C meeting, the FDA acknowledged the unmet need for reducing recurrent exacerbations during the vulnerable 28-day period following an acute exacerbation of asthma or COPD,” he said. “In our previously completed phase 2 study for the maintenance treatment of asthma, a 600 mg subcutaneous loading dose of rademikibart was well-tolerated and delivered robust improvement in pulmonary function in less than 24 hours.”
Dr. Quart said this data could provide meaningful and rapid benefit to millions of patients who are seen in emergency departments or are hospitalized every year.
Mario Castro, MD, MPH, professor and chief of pulmonary, critical care and sleep medicine at the University of Kansas School of Medicine, praised the news of the trials, citing a growing need for treatments of this kind.
“Asthma and COPD patients face a heightened risk of further exacerbations within the first 28 days following an initial episode,” he said. “While biologics have demonstrated significant success in maintenance therapy, none have been approved to address airway symptoms immediately after an acute exacerbation.”
Based on the advice from the FDA during the meeting, Connect Biopharma plans to start enrolling patients in these new trials in the second quarter of 2025. The two parallel, randomized, double-blind, placebo-controlled trials are expected to enroll approximately 160 patients and include those with uncontrolled, moderate-to-severe asthma or COPD who are experiencing acute exacerbations.
The trials will evaluate a single 600 mg dose of rademikibart in patients over 28 days following an acute exacerbation. Connect Biopharma expects to report data from both phase 2 trials in the first half of 2026.
