Late Breaking Abstract - Phase 2 trial of HSK31858, a novel DPP1 inhibitor, in bronchiectasis

<bold>Background:</bold> Bronchiectasis is a suppurative lung disease which might benefit from dipeptidylpeptidase-1inhibitor treatment. <bold>Objective:</bold> To evaluate the effects of HSK31858 in Chinese adults with bronchiectasis. <bold>Methods:</bold> This was a phase II, randomized, double-blind, placebo-controlled study. Bronchiectasis patients with ≥2 annual exacerbations received placebo, 20mg HSK31858, or 40mg HSK31858 (1:1:1) for 24 weeks. The primary end point was the exacerbation frequency. <bold>Results:</bold> Overall, 75 patients were allocated to placebo group, 75 to 20mg HSK31858 group, and 76 to 40mg HSK31858 group. Both 20 mg (HR=0.52, 95%CI: 0.34-0.79) and 40 mg HSK31858 (HR=0.40, 95%CI: 0.25-0.64) markedly reduced exacebation frequency compared with placebo. Both HSK31858 20mg (147.2 days vs. 124.1 days, P=0.0038) and 40mg (146.2 days vs. 124.1 days, P=0.0089) yielded notably longer mean duration to the first exacerbation. 20mg HSK31858 significantly reduced sputum purulence score compared with placebo (P=0.0007). The incidence of treatment-emergent adverse events in HSK31858 20mg (86.5% vs. 85.3%, P>0.05) and 40mg groups (88.0% vs. 85.3%, P>0.05) was comparable with that in placebo group. <bold>Conclusion:</bold> HSK31858 is safe and effective for ameliorating neutrophilic inflammation in bronchiectasis. Figure 1. Time to the first exacerbation (A) and sputum NSPs activity (B) <fig><object-id>erj;64/suppl_68/PA3001/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.pa3001
Citations
3
Primary Topic
Cystic Fibrosis Research Advances
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article
Field-Weighted Citation Impact
1.26
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article

Late Breaking Abstract - Phase 2 trial of HSK31858, a novel DPP1 inhibitor, in bronchiectasis

Rongliang Qiu, Hua Zhou, Yuanlin Song, Zhiyuan Yang et al.
3 citations
Cystic Fibrosis Research Advances
1.26
article

Late Breaking Abstract - Phase 2 trial of HSK31858, a novel DPP1 inhibitor, in bronchiectasis

Rongliang Qiu, Hua Zhou, Yuanlin Song, Zhiyuan Yang, Zuke Xiao, Hao Xiong, Lingyun Gao, Huan Ye, Jin‐Fu Xu, Yaochun Shen, Lizhong Zhao, Jie Cao, Shilin Xie, Yanming Huang, Fuqiang Wen, Yingxiang Lin, Guojun Zhang, Xian‐Ming Zhang, Xingxiang Xu, Lingwei Wang, Wei‐jie Guan, Dianjie Lin, X. Zhang, Nanshan Zhong, Yuanyuan Li
article en
3 citations

Abstract

<bold>Background:</bold> Bronchiectasis is a suppurative lung disease which might benefit from dipeptidylpeptidase-1inhibitor treatment. <bold>Objective:</bold> To evaluate the effects of HSK31858 in Chinese adults with bronchiectasis. <bold>Methods:</bold> This was a phase II, randomized, double-blind, placebo-controlled study. Bronchiectasis patients with ≥2 annual exacerbations received placebo, 20mg HSK31858, or 40mg HSK31858 (1:1:1) for 24 weeks. The primary end point was the exacerbation frequency. <bold>Results:</bold> Overall, 75 patients were allocated to placebo group, 75 to 20mg HSK31858 group, and 76 to 40mg HSK31858 group. Both 20 mg (HR=0.52, 95%CI: 0.34-0.79) and 40 mg HSK31858 (HR=0.40, 95%CI: 0.25-0.64) markedly reduced exacebation frequency compared with placebo. Both HSK31858 20mg (147.2 days vs. 124.1 days, P=0.0038) and 40mg (146.2 days vs. 124.1 days, P=0.0089) yielded notably longer mean duration to the first exacerbation. 20mg HSK31858 significantly reduced sputum purulence score compared with placebo (P=0.0007). The incidence of treatment-emergent adverse events in HSK31858 20mg (86.5% vs. 85.3%, P>0.05) and 40mg groups (88.0% vs. 85.3%, P>0.05) was comparable with that in placebo group. <bold>Conclusion:</bold> HSK31858 is safe and effective for ameliorating neutrophilic inflammation in bronchiectasis. Figure 1. Time to the first exacerbation (A) and sputum NSPs activity (B) <fig><object-id>erj;64/suppl_68/PA3001/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>

Central South University (CN), Nanchang University (CN), Guiyang Medical University (CN), Anhui Medical University (CN), Sichuan University (CN), Fudan University (CN), Beijing Chao-Yang Hospital, Capital Medical University (CN), Tianjin Medical University General Hospital (CN), West China Hospital of Sichuan University (CN), Suizhou Central Hospital (CN), Fourth People's Hospital of Sichuan Province (CN), First Affiliated Hospital of Guangzhou Medical University (CN), ShenZhen People’s Hospital (CN), Jiangxi Provincial People's Hospital (CN), Affiliated Hospital of Guizhou Medical University (CN), Zhongshan Hospital (CN), Shanghai Pulmonary Hospital (CN), Pudong Medical Center (CN), First Affiliated Hospital of Anhui Medical University (CN), Northern Jiangsu People's Hospital (CN), Jiangmen Central Hospital (CN), Shandong Chest Hospital (CN), Zhengzhou People's Hospital (CN), Wenzhou City People's Hospital (CN), Jinan Infectious Disease Hospital (CN), First Affiliated Hospital of Zhengzhou University (CN), Second People’s Hospital of Yibin (CN), Xiangya Hospital Central South University (CN), First Affiliated Hospital of Nanchang University (CN), First Affiliated Hospital Zhejiang University (CN), China Medical University (CN), Guangzhou Medical University (CN)
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Openalex Percentile: Top 18%
Cystic Fibrosis Research Advances
1.26
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