Connect Biopharma announced positive feedback from the FDA regarding its plan for two Phase 2 trials of rademikibart. The trials will investigate the drug’s effectiveness in treating acute exacerbations of asthma and COPD in patients with elevated eosinophil levels. The FDA acknowledged the unmet need for treatments targeting the vulnerable 28-day period following these exacerbations.
This development is crucial because current biologic therapies are primarily focused on maintenance treatment, leaving a gap in addressing immediate post-exacerbation symptoms. The positive FDA feedback validates Connect Biopharma’s approach and suggests a potential shift in how these conditions are managed, especially during critical periods of heightened vulnerability. This could significantly improve patient outcomes by reducing the risk of recurring exacerbations and related hospitalizations or emergency department visits.
The two parallel Phase 2 trials are randomized, double-blind, and placebo-controlled. Each trial will enroll roughly 160 patients with moderate-to-severe asthma or COPD and eosinophil counts of 300 cells/µL or higher. The trials will evaluate the effectiveness of a single 600 mg subcutaneous dose of rademikibart administered following an acute exacerbation, with a 28-day follow-up period. Previous Phase 2 data showed that a similar dose of rademikibart was well-tolerated and improved pulmonary function in asthma patients within 24 hours. Connect Biopharma expects to initiate trials in Q2 2025, with data readout expected in the first half of 2026. The company’s current financial runway extends into 2027.
These Phase 2 trials represent a significant step towards addressing a critical unmet need in asthma and COPD treatment. Positive results could pave the way for a new therapeutic approach focusing on rapid intervention following acute exacerbations, potentially improving patient outcomes and reducing healthcare burdens. The data generated will be instrumental in determining the future development and potential market positioning of rademikibart.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
