Connect Biopharma Holdings Ltd., a clinical-stage biopharmaceutical company, has reported positive preliminary results for its phase 1 clinical pharmacology study evaluating intravenous (IV) rademikibart. The drug is an anti-interleukin-4-recepter alpha (IL-4Ra) antibody aimed at treating patients with COPD or asthma.
“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, PharmD, CEO and director of Connect Biopharma, in a press release.
Dr. Quart said the data demonstrated that a single IV administration of rademikibart can quickly improve lung function, with clinically meaningful improvements in forced expiratory volume in one second (FEV1). But the results didn’t stop there.
“[The study] also provides clinical evidence supporting preclinical observations that rademikibart appears to produce bronchodilation independently from blocking IL-4ra,” he said. “The unique effect of rademikibart on lung function is dually suited to potentially treat acute exacerbations and be a best-in-class chronic treatment.”
Part A of the single-dose, placebo-controlled phase 1 study evaluated IV infusion rates of 300 mg of rademikibart or placebo in healthy volunteers. In part B of the study, adult patients with stable asthma and stable COPD were randomized 4:1 to a single, 300 mg dose of rademikibart or placebo (12 patients in asthma and 10 in COPD).
Key preliminary results included:
- The 300 mg dose of rademikibart administered by a two-minute IV push produced significantly faster improvement in FEV1 than what had been previously observed with a 600 mg subcutaneous administration. Improvement was observed in many asthma and COPD patients as early as 15 minutes after dosing.
- Mean FEV1 improvements from a baseline of ~200-400 mL in patients receiving rademikibart were generally maintained through day 29 in both asthma and COPD patients. Placebo patients in both cohorts trended down.
- Rademikibart was generally well-tolerated with no serious adverse events, no severe adverse events and no adverse events leading to study discontinuation.
Connect Biopharma expects to report topline data from two ongoing phase 2 studies of rademikibart in mid-2026 and plans to meet with the U.S. Food and Drug Administration to gain alignment on a phase 3 study.
