Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Rα, in Adult Chinese Patients With Asthma.
Mo Xian, Xu Shi, Ruoran Li et al.
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In 30 seconds
This Phase Ib/II randomized controlled trial evaluated the efficacy, safety, and pharmacodynamics of MG-K10, a monoclonal antibody targeting IL-4Rα, in Chinese adults with moderate-to-severe asthma. The study found that at week 12, both MG-K10 dosing regimens significantly improved prebronchodilator FEV1 compared to placebo, with Q2W showing a mean improvement of 0.35 L and Q4W 0.30 L (both p < 0.0001).
Key findings
- MG-K10 Q2W improved prebronchodilator FEV1 by 0.35 L compared to placebo (p < 0.0001).
- MG-K10 Q4W improved prebronchodilator FEV1 by 0.30 L compared to placebo (p < 0.0001).
- Both MG-K10 groups showed similar incidence of adverse events, around 79-85%.
- Greater FEV1 improvements were noted in patients with baseline eosinophils ≥ 0.3 × 10^9/L.
Why it matters
The findings suggest that MG-K10 may provide significant benefits in lung function and asthma control for patients with moderate-to-severe asthma, potentially improving adherence with its less frequent dosing schedule.