GST-HG171 / Fujian Cosunter - LARVOL DELTA

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