BEIJING (dpa-AFX) - Clinical-stage biopharmaceutical company Connect Biopharma Holdings Ltd. (CNTB) Tuesday announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation.
'We are pleased to have the FDA's alignment on our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD, an area where no biologic therapies have been approved or systematically studied,' said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma.
'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. In our previously completed Phase 2 study for the maintenance treatment of asthma, a 600 mg subcutaneous (SC) loading dose of rademikibart was well-tolerated and delivered robust improvement in pulmonary function in less than 24 hours. This promising data suggests that rademikibart could provide meaningful and rapid benefit to the millions of patients who experience exacerbations of asthma or COPD and are seen in emergency departments or are hospitalized each year.'
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