The Phase II clinical study for the treatment of sepsis in China of the global innovative drug STC3141, which is developed by Grand Pharma’s wholly-owned subsidiary Grand Medical Pty Ltd. (an innovative drug R&D center set up by the Group in Australia), has completed all patient’s enrollment and dosing recently. Preliminary clinical results are expected in March 2025. This is another important R&D progress of the Group in the field of severe disease anti-infection.
The study is a multi-center, randomized, double-blinded, placebo-controlled Phase II dose-exploring clinical study. It plans to enroll 180 sepsis patients receiving standard treatment and care, with continuous dosing for 5 days by intravenously administration, and follow up to day 28 to evaluate the efficacy, safety and pharmacokinetics of different doses of STC3141 in patients with sepsis.
Previously, the Phase Ib clinical study of STC3141 for the treatment of sepsis in Australia and Belgium, the Phase Ib clinical study of acute respiratory distress syndrome (ARDS) in China, and the Phase IIa clinical study in Europe to treat severe SARS-CoV-2 infection (COVID-19) have all indicated the product’s favorable safety and tolerability, as well as the positive signals in terms of effectiveness indicators such as helping patients getting off the ventilator and vasopressors, and shortening the length of ICU hospitalization.
The product has a novel mechanism and the results of related preclinical research have been published in the top academic journal Nature Communications and Critical Care in February 2020 and November 2023, respectively, which has far-reaching academic influence.
The field of respiratory and severe disease anti-infection is one of the core strategic areas of the Group. STC3141, a global innovative product with a new mechanism, can neutralize extracellular protein and neutrophils trap net to reverse the body organ damage caused by the excessive immune response, and can be used for a variety of severe indications, such as sepsis, ARDS and other diseases with high clinically mortality and lack of effective therapy.
The Group always puts focus on the R&D of innovative products and advanced technologies. Adhering to a patient-centered and innovation-driven approach, the Group will continue to increase its investment in world-class innovative products and advanced technologies to meet unmet clinical needs and enrich its product pipeline and improve supply chain. The Group adopts the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other. In this way, the Group can make full use of its industrial advantages and R&D capabilities, to accelerate the commercialization process for innovative products and provide patients with more advanced and diverse treatment options globally.
