更新于：2024-11-04
Fujian Akeylink Biotechnology Co., Ltd
福建广生中霖生物科技有限公司|
私营公司 | 子公司|
2021|
中国福建省
更新于：2024-11-04
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A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole With GST-HG171/Ritonavir in Healthy Adult Chinese Participants
Food Effects Study of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
100 项与 福建广生中霖生物科技有限公司 相关的临床结果
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2024-05-01EClinicalMedicine
Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial
Article
作者: Mao, John ; Li, Hongming ; Chen, Xiaochun ; Zhong, Nanshan ; Fu, Haijun ; Zhang, Kaiyu ; Lin, Feng ; Wang, Fu-Sheng ; Lu, Hongzhou ; Yang, Zifeng ; Lin, Yihua ; Li, Guoping ; Liang, Zhenyu ; Zhang, George ; Chen, Xinwen ; Tan, Hongshan ; Yan, Wenhao ; Lin, Yuanlong ; Huo, Liya ; Huang, Fuhu ; Zhan, Yangqing ; Yuan, Wenfang ; Chen, Xia ; Hu, Peng ; Lin, Zhuhua ; Mu, Lisa ; Tang, Yanan ; Zhang, Tianxiang ; Lin, Ling ; Tu, Xinyu ; Hu, Zhiqiang ; Sun, Ruilin ; Yan, Xiuping ; Wei, Zhaohui ; Zhu, Feiyue ; Zhuang, Xibin ; Zeng, Yiming
Background:
GST-HG171 is a potent, broad-spectrum, orally bioavailable small-molecule 3C like protease inhibitor that has demonstrated greater potency and efficacy compared to Nirmatrelvir in pre-clinical studies. We aimed to evaluate the efficacy and safety of orally administered GST-HG171 plus Ritonavir in patients with coronavirus disease 2019 (COVID-19) infected with emerging XBB and non-XBB variants.
Methods:
This randomised, double-blind, placebo-controlled phase 2/3 trial was conducted in 47 sites in China among adult patients with mild-to-moderate COVID-19 with symptoms onset ≤72 h. Eligible patients were randomised 1:1 to receive GST-HG171 (150 mg) plus Ritonavir (100 mg) or corresponding placebo tablets twice daily for 5 days, with stratification factors including the risk level of disease progression and vaccination status. The primary efficacy endpoint was time to sustained recovery of clinical symptoms within 28 days, defined as a score of 0 for 11 COVID-19-related target symptoms for 2 consecutive days, assessed in the modified intention-to-treat (mITT) population. This trial was registered at ClinicalTrials.gov (NCT05656443) and Chinese Clinical Trial Registry (ChiCTR2200067088).
Findings:
Between Dec 19, 2022, and May 4, 2023, 1525 patients were screened. Among 1246 patients who underwent randomisation, most completed basic (21.2%) or booster (74.9%) COVID-19 immunization, and most had a low risk of disease progression at baseline. 610 of 617 who received GST-HG171 plus Ritonavir and 603 of 610 who received placebo were included in the mITT population. Patients who received GST-HG171 plus Ritonavir showed shortened median time to sustained recovery of clinical symptoms compared to the placebo group (13.0 days [95.45% confidence interval 12.0-15.0] vs. 15.0 days [14.0-15.0], P = 0.031). Consistent results were observed in both SARS-CoV-2 XBB (45.7%, 481/1053 of mITT population) and non-XBB variants (54.3%, 572/1053 of mITT population) subgroups. Incidence of adverse events was similar in the GST-HG171 plus Ritonavir (320/617, 51.9%) and placebo group (298/610, 48.9%). The most common adverse events in both placebo and treatment groups were hypertriglyceridaemia (10.0% vs. 14.7%). No deaths occurred.
Interpretation:
Treatment with GST-HG171 plus Ritonavir has demonstrated benefits in symptom recovery and viral clearance among low-risk vaccinated adult patients with COVID-19, without apparent safety concerns. As most patients were treated within 2 days after symptom onset in our study, confirming the potential benefits of symptom recovery for patients with a longer duration between symptom onset and treatment initiation will require real-world studies.
Funding:
Fujian Akeylink Biotechnology Co., Ltd.
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