Grand Pharma’s Global Innovative Product STC3141 Achieved the Clinical Endpoint of The Phase Ib Clinical Trial for the Treatment of ARDS in China
- According to the data analysis of the clinical trial, in the primary endpoint of the study, STC3141 did not suggest any potential serious safety problems or unexpected results in the overall safety profile, showing favorable safety and tolerance;
- In the analysis of the secondary endpoint of efficacy, STC3141 showed positive signals compared with standard treatment method in terms of alleviating the severity of ARDS, improving the prognosis of ARDS patients, helping ARDS patients to be weaned off the ventilator and shortening the ICU length of stay;
- The Phase IIa clinical study of STC3141 for the treatment of severe COVID-19 patients conducted in Europe has also achieved its clinical endpoint, with no serious drug-related adverse reactions, and the patients were well tolerated.
HONG KONG SAR - Media OutReach - 31 October 2022 - Grand Pharmaceutical Group Limited ("Grand Pharma", stock code: 00512) announced that that the global innovative drug STC3141 in the field of severe disease, which is developed by its wholly-owned subsidiary Grand Medical Pty Ltd (an innovative drug R&D center set up by Grand Pharma in Australia), has successfully achieved the clinical study endpoint of the phase Ib clinical trial for the treatment of acute respiratory distress syndrome ("ARDS") in China ("NCT05000671").
NCT05000671 is a randomized, double-blind, placebo-controlled Phase Ib clinical study for investigating and evaluating the safety, tolerability and pharmacokinetics of the drug in patients with ARDS. The study received clinical approval for conducting clinical study from the National Medical Products Administration of the People's Republic of China (NMPA) in March 2021 and completed the first patient enrollment in October, enrolled all patients in July 2022, and completed all follow-up and data analysis recently. A total of 16 evaluable subjects were enrolled in the study. All patients received standard intensive care unit ("ICU") supported treatment and care appropriate to their conditions, adopting the principle of continuous 72-hour intravenous administration and dose-escalation grouped dosing. Subjects in each group were continuously observed until the 28th day after receiving treatment.
According to the data analysis of the clinical trial, in the primary endpoint of the study, STC3141 did not suggest any potential serious safety problems or unexpected results in the overall safety profile, showing favorable safety and tolerance. Meanwhile, in the analysis of the secondary endpoint of efficacy, STC3141 showed positive signals compared with standard treatment method in terms of alleviating the severity of ARDS, improving the prognosis of ARDS patients, helping ARDS patients to be weaned off the ventilator and shortening the ICU length of stay. It provides a solid foundation for further clinical research of the product.
ARDS is one of the main causes of death in ICU patients, and currently there is no effective medication treatment method in clinical practice. According to a statistical data related to nearly 30,000 patients in 459 ICUs of 50 countries around the world, the prevalence of ARDS is approximately 10.4% in critically ill patients, the overall mortality rate is approximately 34% in hospital, and mortality rate is approximately 60% in severe patients. In addition, among patients with severe COVID-19, ARDS is also one of the main causes of death, indicating an urgent clinical demand and tremendous market prospect.
STC3141 is a global innovative small molecule compound with a new mechanism of action independently developed by Grand Pharma. It can reverse the organ damage caused by the body's excessive immune response by neutralizing extracellular free histones and neutrophil traps, and can be used for a variety of severe indications. The relevant preclinical research results of the product have been published in the top academic journal "Nature Communications" in February 2020, which has far-reaching academic influence.
In terms of clinical research, in addition to the Phase Ib clinical study for the treatment of ARDS patients conducted in China, the Phase IIa clinical study of STC3141 for the treatment of severe COVID-19 patients conducted in Europe has also achieved its clinical endpoint, with no serious drug-related adverse reactions, and the patients were well tolerated. Moreover, the product has approved to conduct Phase Ib clinical studies for the treatment of sepsis in Australia in May 2020 and in Belgium in April 2022, respectively, comprehensively promoting the international multi-center clinical trials.
Grand Pharma commented, "The achievement of the clinical endpoint in the Phase Ib clinical study in China of this project is not only an important milestone in the Group's global clinical research process, but also provide solid data support for the subsequent clinical development of the product. In the future, the Group will continue to adopt the R&D concept of independent R&D and global expansion to create a full-cycle management product cluster for chronic airway diseases and a pipeline of anti-infection products for severe diseases, so as to continuously strengthen the Group's industry position in this field."
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