Efficacy and safety of CM310 in moderate to severe asthma: a multicenter, randomized, double-blind, placebo-controlled phase 2 study

<bold>Background:</bold> CM310 is a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody, inhibits IL-4 and IL-13 signaling which contribute to the pathophysiology of asthma. This study (<ext-link>NCT05186909</ext-link>) aimed to evaluate the efficacy and safety of CM310 in patients (pts) with moderate to severe asthma. <bold>Methods:</bold> In this phase 2 study, pts were randomly assigned (1:1:1) to receive CM310 300 mg, 150 mg, or placebo administered subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change from baseline to week 12 in prebronchodilator FEV1. <bold>Results:</bold> 52 pts were enrolled in CM310 300 mg (n=18), 150 mg (n=16), or placebo group (n=18) with baseline mean prebronchodilator FEV1 of 1.50, 1.43 and 1.33 L respectively. Compared with placebo, change from baseline in prebronchodilator FEV1 at week 12 was greater with CM310 300 mg and 150 mg (LS mean difference, 99.0 [95% CI -243.4-441.4] mL and 342.0 [95% CI 75.0-676.3] mL). CM310 300 mg reduced annualized asthma exacerbation rate over 24 weeks by 53.9% (RR=0.46) and by 84.7% with 150 mg (RR=0.15) vs. placebo. Significant improvement in ACQ-5 score with CM310 300 mg and 150 mg vs. placebo by 0.86 and 0.60 points was seen early at week 2, and was maintained till week 24. The incidence of treatment emergent adverse events (TEAEs) was 100%, 93.8%, 83.3% for CM310 300 mg, 150 mg, placebo group, and most were grade 1-2 (≥ grade 3 TEAEs: 5.6% vs. 12.5% vs. 16.7%). <bold>Conclusion:</bold> CM310 was well tolerated and resulted in clinically meaningful improvement in pulmonary function and quality of life, reductions in asthma exacerbations in the pts with moderate to severe asthma.

Authors

Institutions

Publication Details

Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa2982
Primary Topic
Asthma and respiratory diseases
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Efficacy and safety of CM310 in moderate to severe asthma: a multicenter, randomized, double-blind, placebo-controlled phase 2 study

Anbo Xiang, Liming Peng, Zuke Xiao, Zihan Wang et al.
Asthma and respiratory diseases
article

Efficacy and safety of CM310 in moderate to severe asthma: a multicenter, randomized, double-blind, placebo-controlled phase 2 study

Anbo Xiang, Liming Peng, Zuke Xiao, Zihan Wang, Nan Su, Yiyi Jiang, Wenjuan Wang, Jie Li, Zhihong Chen, Chunxiao Li, Xiaomeng Qi, Changqing Lin, Ling Zhang, Haihong Wu, Xiangjie Zhang, Junzhen Gao, Shengyu Wang, Jingbo Qiu, Chen Wang, Dong Zhang
article en

Abstract

<bold>Background:</bold> CM310 is a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody, inhibits IL-4 and IL-13 signaling which contribute to the pathophysiology of asthma. This study (<ext-link>NCT05186909</ext-link>) aimed to evaluate the efficacy and safety of CM310 in patients (pts) with moderate to severe asthma. <bold>Methods:</bold> In this phase 2 study, pts were randomly assigned (1:1:1) to receive CM310 300 mg, 150 mg, or placebo administered subcutaneously every 2 weeks for 24 weeks. The primary endpoint was change from baseline to week 12 in prebronchodilator FEV1. <bold>Results:</bold> 52 pts were enrolled in CM310 300 mg (n=18), 150 mg (n=16), or placebo group (n=18) with baseline mean prebronchodilator FEV1 of 1.50, 1.43 and 1.33 L respectively. Compared with placebo, change from baseline in prebronchodilator FEV1 at week 12 was greater with CM310 300 mg and 150 mg (LS mean difference, 99.0 [95% CI -243.4-441.4] mL and 342.0 [95% CI 75.0-676.3] mL). CM310 300 mg reduced annualized asthma exacerbation rate over 24 weeks by 53.9% (RR=0.46) and by 84.7% with 150 mg (RR=0.15) vs. placebo. Significant improvement in ACQ-5 score with CM310 300 mg and 150 mg vs. placebo by 0.86 and 0.60 points was seen early at week 2, and was maintained till week 24. The incidence of treatment emergent adverse events (TEAEs) was 100%, 93.8%, 83.3% for CM310 300 mg, 150 mg, placebo group, and most were grade 1-2 (≥ grade 3 TEAEs: 5.6% vs. 12.5% vs. 16.7%). <bold>Conclusion:</bold> CM310 was well tolerated and resulted in clinically meaningful improvement in pulmonary function and quality of life, reductions in asthma exacerbations in the pts with moderate to severe asthma.

Xinjiang Medical University (CN), Shanxi Medical University (CN), Fudan University (CN), China-Japan Friendship Hospital (CN), First Affiliated Hospital of Xinjiang Medical University (CN), Jinshan Hospital of Fudan University (CN), Jiangxi Provincial People's Hospital (CN), Xi'an Medical University (CN), Gannan Medical University (CN), Jiangxi Pingxiang People's Hospital (CN), Zhongshan Hospital (CN), Hainan General Hospital (CN), Second Hospital of Shanxi Medical University (CN), First Affiliated Hospital of Gannan Medical University (CN), Huizhou Central People's Hospital (CN), The Affiliated Hospital to Changchun University of Chinese Medicine (CN), Henan Provincial Chest Hospital (CN), Shijiazhuang Yiling Pharmaceutical (China) (CN), Xinxiang Central Hospital (CN), Qujiang People's Hospital (CN), Baotou Medical College (CN), Inner Mongolia Medical University (CN)
Good health and well-being
Openalex Percentile: Top 72%
Asthma and respiratory diseases
DOISourceOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.