Connect Biopharma reports rademikibart asthma data
Full story: https://grafa.com/en/news/united-states/connect-biopharma-rademikibart-phase-2-asthma-data
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Connect Biopharma reported positive preliminary Phase 2 results for rademikibart in acute asthma exacerbations.
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The treatment showed a statistically significant improvement in lung function at Day 7 compared with placebo.
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The company plans further regulatory discussions after additional COPD trial data.
Connect Biopharma (NASDAQ:CNTB) reported preliminary topline Phase 2 results from the Seabreeze STAT Asthma study showing rademikibart improved lung function as an add-on treatment for acute asthma exacerbations with type 2 inflammation.
The randomized, double-blind, placebo-controlled study enrolled 160 participants who received a 600 mg subcutaneous dose of rademikibart plus standard care or placebo, with the primary analysis showing a Day 7 post-bronchodilator FEV1 improvement.
Rademikibart produced a mean FEV1 increase of 250 mL compared with 120 mL for placebo, representing a 130 mL difference with a p-value of 0.023, while treatment failure over 28 days was reduced by about 66% compared with placebo.
Connect Biopharma said the treatment was well tolerated, with safety results comparable to placebo and fewer serious adverse events, while additional Phase 2 COPD data are expected later this month.
Connect Biopharma develops antibody therapies targeting inflammatory diseases, including respiratory conditions associated with type 2 inflammation.
The company plans to use upcoming COPD results to support discussions with the U.S. Food and Drug Administration regarding a potential Phase 3 development program.
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