Connect Biopharma Holdings ( (CNTB) ) has provided an announcement.
On April 1, 2025, Connect Biopharma announced positive feedback from its Type C meeting with the FDA, which has aligned on the company’s plan to initiate parallel Phase 2 trials of rademikibart for patients with moderate-to-severe asthma or COPD experiencing acute exacerbations. These trials, set to begin in the second quarter of 2025, aim to enroll approximately 160 patients each and will evaluate the efficacy of a single 600 mg subcutaneous dose of rademikibart over 28 days. The company expects to report data from these trials in the first half of 2026, potentially impacting the treatment landscape for asthma and COPD by addressing a significant unmet need.
More about Connect Biopharma Holdings
Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company focused on transforming the acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD). Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, with a focus on addressing acute exacerbations in asthma and COPD.
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