China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib REFINE study for its drug candidate STC3141 in sepsis has successfully reached the clinical endpoint in Australia and Belgium.
Design and Results of the Phase Ib REFINE Study
The open-label, multi-center, dosage escalation Phase Ib clinical study was approved in Australia and Belgium in April 2020 and April 2022, respectively. The study aimed to assess the safety, tolerability, drug metabolism characteristics, and preliminary efficacy of STC3141 in sepsis patients with varying degrees of renal dysfunction in the intensive care unit (ICU). Enrolling 26 evaluable cases, the study demonstrated that STC3141 showed good overall safety and tolerability as the primary endpoint. In the secondary endpoint analysis of efficacy, STC3141 exhibited positive signals in assisting patients in weaning off ventilators, weaning off booster drugs, and shortening ICU hospitalization time, with efficacy being dose-dependent.
STC3141’s Mechanism of Action and Potential Impact
STC3141 is a novel first-in-class small-molecule compound with a new mechanism of action independently developed by Grand Pharmaceutical Group. It can reverse organ damage caused by the body’s excessive immune response by neutralizing extracellular free histones and neutrophil traps. This unique mechanism of action complements that of GPN00068 (APAD), another sepsis drug candidate from Grand Pharma that received approval for a Phase I study in healthy subjects in China in March this year.-Fineline Info & Tech
