China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that all patients have completed enrollment and dosing in the Phase Ib REFINE study for its drug candidate STC3141 in sepsis in Australia and Belgium. The first data readout is expected in four months’ time, marking a significant milestone in the development of this innovative treatment.
Phase Ib REFINE Study Details
The open-label, multi-center, dosage escalation Phase Ib clinical study was approved in Australia in April 2020 and in Belgium in April 2022. The study enrolled 26 sepsis patients requiring intensive care unit (ICU) treatment to assess the safety, drug metabolic characteristics, and preliminary efficacy of the drug in sepsis patients with different degrees of renal function damage in ICU. The Phase Ia study in healthy subjects, concluded in Australia, preliminarily confirmed its safety and metabolic characteristics.
STC3141: First-in-Class Small-Molecule Compound
STC3141 is a novel first-in-class small-molecule compound with a new mechanism of action independently developed by Grand Pharmaceutical Group. The drug can reverse organ damage caused by the body’s excessive immune response by neutralizing extracellular free histones and neutrophil traps. This innovative approach has the potential to significantly improve outcomes for patients with sepsis and related conditions.
Global Clinical Trials and Patent Protection
The drug has received seven clinical trial approvals in China, Australia, Belgium, the UK, and Poland for the treatment of sepsis and acute respiratory distress syndrome (ARDS), as well as COVID-19 and COVID-19-induced ARDS. STC3141 has been filed for patent protection in 12 countries around the globe, highlighting the company’s commitment to protecting its intellectual property and expanding its global reach.-Fineline Info & Tech
