This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired renal function.

Start Date10 Feb 2023

Sponsor / Collaborator

Fujian Akeylink Biotechnology Co., Ltd

NCT05656443 / CompletedPhase 2/3

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of GST-HG171/Ritonavir in Patients With Mild to Moderate COVID-19

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of GST-HG171/Ritonavir in the treatment of mild to moderate COVID-19.

Start Date19 Dec 2022

Sponsor / Collaborator

Fujian Akeylink Biotechnology Co., Ltd

NCT06106113 / CompletedPhase 1

Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function

Start Date15 Dec 2022

Sponsor / Collaborator

Fujian Akeylink Biotechnology Co., Ltd

100 Clinical Results associated with Atilotrelvir

100 Translational Medicine associated with Atilotrelvir

100 Patents (Medical) associated with Atilotrelvir

Literatures (Medical) associated with Atilotrelvir

07 Aug 2024·Antimicrobial Agents and Chemotherapy

Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function

Article

Author: Yan, Wenhao ; Zhang, Tianxiang ; Li, Chuanjing ; Zhang, Hong ; Zhou, Jing ; Zhang, George ; Ding, Yanhua ; Tang, Yanan ; Mao, John ; Chen, Hong ; Jin, Qinglong

ABSTRACT GST-HG171 is a potent, broad-spectrum, orally bioavailable small-molecule 3C-like (3CL) protease inhibitor that was recently approved for treating mild to moderate coronavirus disease 2019 patients in China. Since cytochrome P450 (CYP) enzymes, primarily CYP3A, are the main metabolic enzymes of GST-HG171, hepatic impairment may affect its pharmacokinetic (PK) profile. Aiming to guide clinical dosing for patients with hepatic impairment, this study, using a non-randomized, open-label, single-dose design, assessed the impact of hepatic impairment on the PK, safety, and tolerability of GST-HG171. Patients with mild and moderate hepatic impairment along with healthy subjects were enrolled ( n = 8 each), receiving a single oral dose of 150 mg GST-HG171, with concurrent administration of 100 mg ritonavir to sustain CYP3A inhibition before and after GST-HG171 administration (−12, 0, 12, and 24 hours). Compared to subjects with normal hepatic function, the geometric least-squares mean ratios (90% confidence intervals) for GST-HG171’s maximum plasma concentration ( Cmax ), area under the concentration-time curve up to the last quantifiable time (AUC 0- t ), and area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC 0-∞ ) in subjects with mild hepatic impairment were 1.14 (0.99, 1.31), 1.07 (0.88, 1.30), and 1.07 (0.88, 1.29), respectively. For moderate hepatic impairment, the ratios were 0.87 (0.70, 1.07), 0.82 (0.61, 1.10), and 0.82 (0.61, 1.10), respectively. Hepatic impairment did not significantly alter GST-HG171’s peak time ( Tmax ) and elimination half-life ( T1/2 ). GST-HG171 exhibited good safety and tolerability in the study. Taken together, mild to moderate hepatic impairment minimally impacted GST-HG171 exposure, suggesting no need to adjust GST-HG171 dosage for patients with mild to moderate hepatic impairment in the clinic. Clinical Trials Registered at ClinicalTrials.gov ( NCT06106113 ).

01 May 2024·eClinicalMedicine

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

Author: Hu, Zhiqiang ; Mu, Lisa ; Chen, Xiaochun ; Lin, Ling ; Hu, Peng ; Lin, Feng ; Zhan, Yangqing ; Zhong, Nanshan ; Wei, Zhaohui ; Lu, Hongzhou ; Zhuang, Xibin ; Yan, Wenhao ; Lin, Yihua ; Li, Guoping ; Zhang, Kaiyu ; Mao, John ; Tan, Hongshan ; Zhang, George ; Fu, Haijun ; Tu, Xinyu ; Huo, Liya ; Zhu, Feiyue ; Yan, Xiuping ; Yang, Zifeng ; Sun, Ruilin ; Lin, Yuanlong ; Li, Hongming ; Lin, Zhuhua ; Zhang, Tianxiang ; Zeng, Yiming ; Chen, Xia ; Wang, Fu-Sheng ; Liang, Zhenyu ; Chen, Xinwen ; Yuan, Wenfang ; Huang, Fuhu ; Tang, Yanan

BackgroundGST-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.MethodsThis 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).FindingsBetween 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.InterpretationTreatment 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.FundingFujian Akeylink Biotechnology Co., Ltd.

100 Deals associated with Atilotrelvir

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Indication	Highest Phase	Country/Location	Organization	Date
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