Grand Pharmaceutical Group Limited (HKG: 0512), a China-based pharmaceutical company, has announced that it has received approval to conduct a Phase II clinical study for its drug candidate STC3141 in the treatment of sepsis in China.
Design and Scope of the Phase II Study
The Phase II study is a multi-center, randomized, double-blinded, placebo-controlled dosage exploration study. It is expected to enroll 180 sepsis patients who are receiving standard treatment and care. The study will involve intravenous administration of the drug for a period of 5 days, with follow-ups continuing up to day 28. The primary objectives are to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of STC3141 in sepsis patients.
STC3141: A Promising Treatment for Sepsis
STC3141 is a novel first-in-class small-molecule compound with a unique mechanism of action, independently developed by Grand Pharmaceutical Group. It has the potential to reverse organ damage caused by the body’s excessive immune response by neutralizing extracellular free histones and neutrophil traps. The drug has been approved for clinical studies in COVID-19 induced Acute Respiratory Distress Syndrome (ARDS) in multiple countries, including China, Australia, Belgium, the UK, and Poland. Three clinical studies for STC3141 have been concluded to date.
Complementary Mechanism with GPN00068 (APAD)
STC3141 reportedly has a complementary mechanism of action with GPN00068 (APAD), another sepsis drug candidate in Grand Pharma’s pipeline. GPN00068 received approval for a Phase I study in healthy subjects in China in March this year. The combination of these two drugs may offer a new approach to treating sepsis, a leading cause of mortality in critically ill patients.-Fineline Info & Tech
