Connect Biopharma announced positive Phase 2 trial results for rademikibart, a potential new biologic treatment for moderate-to-severe uncontrolled asthma. The trial showed rapid and sustained improvement in lung function, significant exacerbation rate reduction, and a favorable safety profile. The findings were published in the •American Journal of Respiratory and Critical Care Medicine•.
This news is potentially groundbreaking for asthma patients, especially those with eosinophilic-driven asthma (≥300 eosinophils/µL). Rademikibart demonstrated a substantial +420 mL improvement in forced expiratory volume (FEV1) compared to placebo at 24 weeks in this patient subgroup. This improvement surpasses the efficacy seen with other currently available biologics, offering a potential new standard of care for a difficult-to-treat patient population. The rapid onset of action, observed as early as one week after the initial dose, is also clinically significant, promising faster relief for patients. Furthermore, the absence of eosinophilia-related adverse events, a concern with some existing biologics, positions rademikibart as a potentially safer treatment option.
The Phase 2 trial enrolled 322 patients who received either 150 mg or 300 mg of rademikibart bi-weekly, or a placebo. Improvements in FEV1 were seen across all high eosinophil subgroups. The study also reported statistically significant improvements in asthma control measures and a reduced number of acute exacerbations in the rademikibart groups compared to the placebo group. The safety profile was favorable, with primarily mild to moderate adverse events and no serious adverse events linked to the treatment.
Following these positive results and subsequent end-of-Phase 2 meeting, Connect Biopharma received FDA clearance to proceed with Phase 3 trials. This sets the stage for potential future approval and commercialization of rademikibart for the maintenance treatment of asthma. The company is also investigating the potential of rademikibart for treating acute exacerbations of asthma and COPD, a critical area of unmet medical need. This expanded focus could significantly broaden the drug’s clinical utility and impact on respiratory disease management.
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.
