GST-HG171 / Fujian Cosunter - LARVOL DELTA

Pharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling. (PubMed, Antimicrob Agents Chemother) - P=N/A | "GST-HG171 was generally tolerated across all groups, but adverse reactions related to hypertriglyceridemia should be monitored. Physiologically based PK modeling supported dose reductions for patients with renal impairment, recommending GST-HG171/ritonavir 100/100 mg twice daily for mild impairment and 50/100 mg twice daily for moderate impairment, administered for 5 days.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT06106126."

Journal • PK/PD data • Dyslipidemia • Hypertriglyceridemia • Infectious Disease • Novel Coronavirus Disease • Renal Disease

Pharmacokinetic drug-drug interaction between the COVID-19 3CL protease inhibitor GST-HG171 and itraconazole in healthy subjects. (PubMed, Antimicrob Agents Chemother) - P1 | "There was no apparent increase in the incidence or severity of AEs during the co-administration period. In conclusion, co-administration of itraconazole, a strong CYP3A4 inhibitor, with GST-HG171/ritonavir resulted in a moderate increase in exposure of GST-HG171 and mild increase in exposure of ritonavir, and it had an acceptable safety profile and was well tolerated in this study.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT06087055."

Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease

Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. (PubMed, Antimicrob Agents Chemother) - P1 | "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). 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 TrialsRegistered at ClinicalTrials.gov (NCT06106113)."

Journal • PK/PD data • Hepatology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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. (PubMed, EClinicalMedicine) - P2/3 | "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. 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. Fujian Akeylink Biotechnology Co., Ltd."

Journal • P2/3 data • Dyslipidemia • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171. (PubMed, Antimicrob Agents Chemother) - P1 | "The PK data obtained from GST-HG171/ritonavir administration guided the selection of appropriate dose for a pivotal phase II/III trial currently in progress. (This study has been registered at ClinicalTrials.gov under identifier NCT05668897)."

Clinical • Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P1 trial

Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2/3 | N=1246 | Completed | Sponsor: Fujian Akeylink Biotechnology Co., Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: Fujian Akeylink Biotechnology Co., Ltd. | Recruiting ➔ Completed | N=130 ➔ 78

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease

Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2/3 | N=1200 | Recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2023 ➔ Jul 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease

Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2/3 | N=1200 | Not yet recruiting | Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia