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Connect Biopharma Announces Positive Type C Meeting with the FDA for Rademikibart
nect Biopharma nect Biopharma (US:CNTB) Newsfilter·2025-04-01 13:00

Core Insights - Connect Biopharma is set to initiate parallel Phase 2 trials for rademikibart in patients with moderate-to-severe asthma or COPD experiencing acute exacerbations, with trials expected to start in Q2 2025 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [5] - The company is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, targeting acute exacerbations in asthma and COPD [5] Clinical Trials - The two Phase 2 trials will each enroll approximately 160 patients with uncontrolled, moderate-to-severe asthma or COPD, specifically those with eosinophils ≥300 cells/µL [3] - The trials aim to evaluate the effects of a single 600 mg subcutaneous dose of rademikibart over a 28-day period following an acute exacerbation [3] - Previous studies indicated that about 45% of patients receiving standard care experienced treatment failure within 28 days post-exacerbation, highlighting the need for improved treatments [3] Expected Outcomes - Data from the Phase 2 trials is anticipated to be reported in the first half of 2026, with the company having a cash runway into 2027 [3] - Rademikibart has shown promising results in prior studies, demonstrating rapid improvements in pulmonary function within 24 hours [2][5]