Connect Biopharma Unveils Positive Rademikibart Data at ATS 2024 Conference

7 June 2024

Connect Biopharma Holdings Limited, a clinical-stage biopharmaceutical company, announced promising results from their Phase 2b trial for rademikibart, an investigational treatment for moderate-to-severe asthma. Dr. Edward Kerwin presented these findings at the American Thoracic Society (ATS) 2024 International Conference in San Diego, underscoring the potential of rademikibart to enhance lung function and asthma control.

During the trial, both dosages of rademikibart demonstrated significant improvement in lung function, notably in pre-bronchodilator forced expiratory volume over one second (FEV1) by Week 12. Early improvement was evident as soon as Week 1, and these benefits continued through Week 24. An exploratory analysis indicated that patients with eosinophil levels of ≥300 cells/µl experienced further lung function enhancement. Additionally, patient-reported asthma control saw rapid and sustained improvements throughout the 24-week treatment period.

Although the study wasn't designed to measure differences in exacerbation rates among treatment groups, trends indicated a roughly 50% reduction in annualized exacerbations and an extended time to exacerbation. These findings support the efficacy of rademikibart in managing asthma symptoms and reducing exacerbations.

Zheng Wei, Ph.D., Co-Founder and CEO of Connect Biopharma, expressed enthusiasm about the results shared at the ATS conference. He highlighted the company's plans for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the second quarter of 2024. This meeting aims to discuss the Phase 3 regulatory path for rademikibart, marking a critical step towards potential approval and availability for asthma patients.

Connect Biopharma focuses on developing therapies for chronic inflammatory diseases through T cell-driven research. The company's lead product candidate, rademikibart, targets interleukin-4 receptor alpha (IL-4Rα) and is under development for both atopic dermatitis and asthma. Their second product candidate, icanbelimod, is a modulator of S1P1 T cell receptors intended for treating ulcerative colitis.

The promising results from the rademikibart trial mark a significant advancement in asthma treatment, providing hope for patients with moderate-to-severe symptoms. As Connect Biopharma prepares for regulatory discussions with the FDA, the potential for rademikibart to become an approved treatment option could represent a substantial improvement in asthma management, offering better control and quality of life for those affected by this chronic condition.

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