The results showed that the SOFA scores of the drug treatment groups on the 7th day were significantly lower than those of the baseline, especially in the high-dose group, where the decrease was significantly greater than that in the placebo group, of which the difference was statistically significant and clinically significant.
The trend of the secondary endpoints was consistent with the primary endpoints, which was in line with expectations.
STC3141 is the first sepsis treatment program centered on rebuilding immune homeostasis in the world, achieving a major upgrade in the treatment dimension.
HONG KONG, May 7, 2025 /PRNewswire/ -- Grand Pharmaceutical Group Limited (0512.HK, "Grand Pharma" or the "Group") announces that the Phase II clinical study for the treatment of sepsis in China of the global innovative drug STC3141, which is independently developed by the Group, has successfully reached the clinical endpoint. The progress of this clinical study is at the forefront of global sepsis research.
STC3141 is the first sepsis treatment program centered on rebuilding immune homeostasis in the world, achieving a major upgrade in the treatment dimension. On the basis of existing symptomatic supportive treatments such as anti-infection, fluid resuscitation, and maintaining organ function, it precisely regulates the core cause of the disease, immune disorder, to help the body restore balance, filling the current clinical gap in etiology-oriented treatment of sepsis. The success of this clinical study is expected to usher in a new era of sepsis treatment.
A new breakthrough in critical care treatment that may fill clinical gap in sepsis treatment
About the clinical study:
This study is a multi-center, randomized, double-blind, placebo-controlled Phase II dose-finding clinical study, to evaluate the efficacy, safety, and pharmacokinetic features of intravenous infusion of STC3141 injection in patients with sepsis. It enrolled 180 patients with sepsis who received standard treatment and care, continuously dosed the drug for 5 days, and followed up until day 28. The primary clinical endpoint of the study was the change in the Sequential Organ Failure Assessment ("SOFA") score (a standard for diagnosing sepsis and assessing disease severity) from baseline on day 7; Secondary endpoints included effectiveness indicators such as the proportion of subjects whose SOFA score decreased by 25% from baseline on day 7, etc., and safety indicators such as adverse events within 28 days, aiming to explore the effectiveness and safety of different doses of the drug in the treatment of patients with sepsis.
The results showed that the SOFA scores of the drug treatment groups on the 7th day were significantly lower than those of the baseline, especially in the high-dose group, where the decrease was significantly greater than that in the placebo group. The difference was statistically significant and clinically significant. The trend of the secondary endpoints was consistent with the primary endpoints, which was in line with expectations. In addition, STC3141 has favorable safety and tolerability, and its pharmacokinetic characteristics are also in line with expectations. The results confirmed the effectiveness and safety of STC3141 in the treatment of sepsis, bringing new breakthroughs in the field of critical care. Subsequently, the Group will actively conduct in-depth communication with the NMPA, and apply the qualification of breakthrough therapeutic drug designation, so that STC3141 could benefit the vast number of sepsis patients as soon as possible and fill the clinical gap.
About sepsis:
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to acute infection, and is one of the leading causes of death and long-term disability worldwide. Despite the continuous advancement of medical technology, the morbidity and mortality of sepsis remain high. There are approximately 49 million new cases of sepsis worldwide each year, and more than 1/5 of patients die, accounting for approximately 20% of the total global mortality. The incidence of sepsis intensive care units in China is 20.6% to 50.8%, and about 1/3 of patients die in the hospital. In high-income countries, the average full-hospital cost of treating a sepsis patient exceeds US$32,000.
At present, the treatment of sepsis primarily involves anti-infection, fluid resuscitation, and functional support for organ damage, with no targeted treatment method yet. There is a huge unmet clinical demand in the global market for the treatment of severe diseases such as sepsis.
About STC3141:
STC3141 is a small molecule compound with a new mechanism of action that independently developed by the Group with global intellectual property rights. It can reverse organ damage caused by excessive immune responses of the body by neutralizing extracellular free histones and neutrophil trap nets and is applicable to multiple severe diseases. The product has an innovative mechanism, and the results of related preclinical research have been published in the top academic journal "Nature Communications" and "Critical Care", which has far-reaching academic influence.
In terms of clinical development, the Group has adopted a global development strategy, and has obtained seven clinical approvals in five countries on three continents, namely China, Australia, Belgium, the United Kingdom, and Poland. It has completed four clinical studies on patients, and all of them successfully reached the clinical endpoints. Based on the previous Phase Ib clinical studies in Australia and Belgium for the treatment of sepsis, the Phase Ib clinical studies in China for the treatment of acute respiratory distress syndrome (ARDS), and the Phase IIa clinical study in Europe for the treatment of severe SARS-CoV-2 infection (COVID-19), STC3141 has demonstrated favorable safety and tolerability, and has shown 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 Phase II clinical trial for sepsis this time progressed smoothly that it was approved by the NMPA in July 2023, and all subjects were enrolled in December 2024, which is six months ahead of schedule. It fully demonstrates the Group's strong R&D capabilities, and also illustrates the urgent need for targeted therapeutic drugs in the field of critical care. This product is expected to break the long-standing lack of targeted drugs in the field of sepsis, and become the first pioneering breakthrough therapy in the field of critical care, accurately responding to and meeting the urgent needs of clinical treatment.
About Grand Pharma:
Grand Pharma is an international pharmaceutical company of technological innovation. Its core businesses cover three major areas, namely nuclear medicine anti-tumor diagnosis and treatment and cerebrocardiovascular precision interventional diagnosis and treatment technology, pharmaceutical technology and biotechnology. Based on the pharmaceutical and biological industries, the Group focuses on the needs of patients, and take technological innovation as the driving force. In response to the unmet clinical needs, the Group will increase its investment in global innovative products and advanced technologies, enrich and improve its product pipelines, consolidate and strengthen its industrial chain layout, and fully leverage the Group's industrial strengths and R&D capabilities to provide more advanced and diverse treatment solutions to patients worldwide.
