China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib clinical study (NCT05000671) for its drug candidate STC3141 in acute respiratory distress syndrome (ARDS) has reached its primary endpoint. This marks a significant step forward in the development of the drug for this critical condition.
Phase Ib Study Results
The randomized, double-blind, placebo-controlled Phase Ib study was designed to assess the safety, tolerability, and pharmacokinetics of STC3141 in ARDS. The study enrolled 16 evaluable subjects who received 72 continuous hours of intravenous administration of the drug, alongside standard intensive care unit (ICU) support treatment and nursing suitable for their conditions. Each group of subjects was observed continuously until the 28th day after receiving treatment. The results showed that STC3141 reached the primary endpoint, demonstrating no potential serious safety problems or unexpected results, and a good safety and tolerance profile.
Secondary Endpoint Analysis
In the secondary endpoint analysis of efficacy, STC3141 showed positive signals compared with standard treatment. The drug demonstrated the potential to alleviate the severity of ARDS, improve the prognosis of patients with ARDS, help patients get away from ventilators, and shorten the length of stay in the ICU.
STC3141: Mechanism and Development
STC3141 is a novel first-in-class small-molecule compound independently developed by China Grand. It works by neutralizing extracellular free histones and neutrophil traps, thereby reversing the organ damage caused by the body’s excessive immune response. The company expects the molecule to be useful for a variety of severe indications. Previously, STC3141 obtained approval to enter Phase Ib studies in sepsis in Australia (May 2020) and Belgium (April 2022). Additionally, a Phase IIa study for the drug in severe COVID-19 in Europe reached its primary endpoint, with no drug-related serious adverse reactions and a good tolerability profile.-Fineline Info & Tech
