China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced positive results from an investigator-initiated trial (ITT) for its Category 1 product GST-HG171/ritonavir in COVID-19 patients. The randomized, controlled trial was designed to assess the efficacy and safety of the drug in mild/common COVID-19 adult patients and included a test group, a placebo group, and a Paxlovid-positive control group.
Trial Results and Efficacy
According to the notice, Cosunter’s therapeutic regimen produced superior anti-COVID-19 efficacy compared to Paxlovid. The time to nucleic acid negative conversion (median 8.4 days) for COVID-19 patients treated with GST-HG171/ritonavir was significantly better than the positive control Paxlovid (median 9.5 days) and the placebo control (median 10.3 days). The drug also demonstrated a good safety and tolerability profile.
Mechanism and Development
GST-HG171 is a 3CL protease (3CLpro) inhibitor described as having broad-spectrum anti-COVID-19 activities. Ritonavir, an oral anti-virus pharmacokinetic enhancer originated by AbbVie, is used in combination with GST-HG171 to enhance its efficacy. Paxlovid, which received emergency use authorization in China in February 2022, serves as a benchmark in the trial.
Future Outlook
The positive results from the investigator-initiated trial highlight the potential of Cosunter’s GST-HG171/ritonavir regimen to outperform existing treatments for COVID-19. With demonstrated superior efficacy and a favorable safety profile, GST-HG171 is poised to make a significant impact on patient outcomes. Cosunter’s ongoing efforts in clinical development underscore its commitment to advancing innovative treatments for COVID-19.-Fineline Info & Tech
