Connect Biopharma announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), confirming alignment on the plan to initiate two parallel Phase 2 trials for rademikibart. These trials will evaluate rademikibart in patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation.
The FDA acknowledged the unmet need for reducing recurrent exacerbations during the 28-day period following an acute exacerbation of asthma or COPD. Connect plans to begin enrolling patients in these trials during the second quarter of 2025.
Each Phase 2 trial is expected to enroll approximately 160 patients and will evaluate the benefits of a single 600 mg subcutaneous dose of rademikibart over 28 days. Topline data from both studies are anticipated in the first half of 2026, with the company's cash runway projected into 2027.
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