China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the pivotal Phase II/III regulatory clinical study for its Category 1 product, GST-HG171/ritonavir, in mild/moderate COVID-19 patients has been unblinded and has successfully reached its primary endpoint.
Design and Results of the Study
The multi-center, randomized, double-blind, placebo-controlled study aimed to assess the efficacy and safety of GST-HG171 in mild/moderate COVID-19 patients. Subjects were randomly assigned to receive either GST-HG171 tablets (150mg twice a day) and ritonavir tablets or placebo tablets for 5 consecutive days. The primary efficacy endpoint was the time from treatment to the continuous recovery of clinical symptoms within 28 days. The study’s success indicates that GST-HG171, with a single dose of only 150mg twice a day, is expected to become an anti-COVID-19 drug with a lower daily dose and better efficacy compared to similar products.
GST-HG171’s Profile and Potential Impact
GST-HG171 is a 3CL protease (3CLpro) inhibitor with broad-spectrum anti-COVID-19 activities. Ritonavir, an oral anti-virus pharmacokinetic enhancer originally developed by AbbVie, is used in combination with GST-HG171. Early clinical trials have demonstrated GST-HG171’s broad-spectrum antiviral activity against different COVID-19 variants, with superior pharmacodynamic and pharmacokinetic characteristics compared to Paxlovid. The time to nucleic acid negative transformation in COVID-19 patients treated with GST-HG171 was shorter than that with Paxlovid. Additionally, the single dose of GST-HG171 in clinical trials was only 150mg twice a day, which is lower than the 300mg twice a day of Pfizer’s oral drug Paxlovid.-Fineline Info & Tech
