China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced the completion of 1,200 patient enrollment in a Phase II/III clinical study for its Category 1 product, GST-HG171/ritonavir. This multi-center, randomized, double-blind, controlled trial is designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients.
Study Design and Primary Endpoint
Subjects in the study will be randomly assigned to either the experimental group receiving GST-HG171 (150mg twice a day) and Ritonavir, or the placebo group receiving GST-HG171 placebo and Ritonavir blank tablets, for a duration of 5 consecutive days. The primary endpoint of the study is the time from 28 days after treatment to the continuous recovery of clinical symptoms, a measure of the drug’s impact on the disease’s progression.
GST-HG171: A Broad-Spectrum 3CL Protease Inhibitor
GST-HG171 is a 3CL protease (3CLpro) inhibitor with broad-spectrum anti-COVID-19 activities. Early clinical trials have shown that GSTHG171 has broad-spectrum antiviral activity against different COVID-19 variants. It exhibits superior pharmacodynamic and pharmacokinetic characteristics compared to Paxlovid. Notably, the time to achieve a negative nucleic acid transformation in COVID-19 patients was shorter with GST-HG171 than with Paxlovid. In terms of medication dosage, the single dose of GST-HG171 in clinical trials was significantly lower at 150mg (twice a day) compared to the 300mg (twice a day) of Pfizer’s oral drug Paxlovid.-Fineline Info & Tech
