Grand Pharma’s Global Innovative Product STC3141 Made Significant Progress in Clinical Trials in China and Europe
- NCT05000671 Phase Ib clinical study aims to investigate and evaluate the safety, tolerability and pharmacokinetics of the drug in patients with ARDS. It completed the enrollment and dosing of all patients, and the research report is expected to be completed within the next 6 months.
- NCT04880694 Phase IIa clinical study aims to investigate and evaluate the safety, preliminary efficacy and optimal dosing strategy of the drug in the treatment of severe patients with viral pneumonia caused by infection of COVID-19. It achieved the primary clinical study endpoint.
- STC3141 is now conducting Phase Ib clinical studies for the treatment of sepsis in Australia and Belgium, respectively.
(July 27, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that the global innovative drug STC3141 in the field of severe disease, which is developed by the Group’s wholly-owned subsidiary Grand Medical Pty Ltd (an innovative drug R&D center set up by the Group in Australia), completed the enrollment and dosing of all patients in the phase Ib clinical trial for the treatment of acute respiratory distress syndrome (“ARDS”) in China (“NCT05000671”), of which the research report is expected to be completed within the next 6 months; and successfully achieved the primary clinical study endpoint in the Phase IIa clinical trial for the treatment of severe COVID-19 conducted in Europe (“NCT04880694”).
The field of severe disease and anti-infection is one of the core strategic areas of the Group. Based on the in-depth exploration of unsatisfied clinical needs, the Group has forward-looking layout in respect of sepsis, ARDS, COVID-19, and anaphylaxis and other diseases that pose a major threat to human health. It has reserved four global innovative drugs, two of which are global innovative drugs for the treatment of sepsis and ARDS, STC3141 and APAD, a global innovative drug for the treatment of parainfluenza, and a pre-filled adrenaline automatic injection pen.
Based on the glycomics R&D technology platform and mRNA R&D technology platform in the field of severe disease emergency and anti-infection, the Group has established R&D centres in Australia, Belgium and China to develop global innovative products. The Group’s Australia R&D Centre maintains long-term in-depth cooperation with the Australian National University and Griffith University, continuing to develop world-class innovative technology products and therapies. Among them, the parainfluenza project is cooperating with the inventor of Zanamivir and director of the Institute for Glycomics, Griffith University, which is one of the few scientific research institutes in the world focusing on glycomics research and one of the world’s largest scientific research institutes in this area. In terms of mRNA technology R&D, the Group and eTheRNA, Belgium, jointly established Nanjing AuroRNA Biotech mRNA technology platform. It has opened up the vital segments from R&D to manufacturing of mRNA vaccine, and has been developing multiple global innovative R&D projects in the field of infectious disease prevention, tumor immunotherapy and rare diseases.
Looking ahead, the Group will continue to increase investment in technologies and products in the field of severe disease emergency and anti-infection, enriching and improving product pipelines and industrial strategic plan, devoting to solve the unmet clinical needs, and providing advanced and effective treatment solutions for patients around the world.
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 from the National Medical Products Administration of the People’s Republic of China (NMPA) in March 2021, passed the ethics review of the leader entity in May, passed the review of Human Genetic Resources Administration Office of China* (中國人類遺傳資源管理辦公室) in July, completed the first patient enrollment in November, and all patients have been enrolled and dosed recently.
A total of 16 evaluable subjects were enrolled in NCT05000671. 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. It mainly evaluates the safety, tolerability and the pharmacokinetic characteristics of the drug in ARDS patients after dosing, and collects efficacy-related indicators to accumulate more data to comprehensively evaluate the risks and benefits of later clinical trials.
NCT04880694 is a randomized, open-label, multi-center, standard-therapy controlled Phase IIa clinical study for investigating and evaluating the safety, preliminary efficacy and optimal dosing strategy of STC3141 in the treatment of severe patients with viral pneumonia caused by infection of COVID-19. After submitting the clinical trial application (CTA) in March 2021, the study received clinical approval from the drug administration department of Belgium, Poland and the UK, and completed the enrollment and administration of all patients in December 2021. This is the Group’s first clinical study of a First-in-class innovative drug conducted in Europe.
The NCT04880694 study enrolled 25 patients with severe COVID-19 and required hospitalization. The treatment group was given standard treatment for 3 consecutive days, and the control group only received standard treatment. The primary purpose of the study is to monitor the incidence of adverse events (AEs) in patients during the dosing and observation periods (approximately 30 days) to assess the safety of the product. The results of the study showed that the study of STC3141 for the treatment of severe novel coronavirus pneumonia reached the primary endpoint pre-set in the clinical program, with no serious drug-related adverse reactions, and the patients were well tolerated.
ARDS and sepsis are 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 in 50 countries around the world, the prevalence of ARDS is 10.4% in critically ill patients, the overall mortality rate is 34% in hospital, and mortality rate is 60% in severe patients. Sepsis affects more than 31.5 million people worldwide each year, of which over 19.4 million patients are with severe sepsis with mortality rate more than 25%. Among patients with severe COVID-19, ARDS and sepsis are also important causes of death. There is a clear relevance between the two pathogenic mechanisms. However, there is a lack of targeted drugs in the market, 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 the Group. It can reverse the organ damage caused by the body’s excessive immune response by neutralizing extracellular free histones and neutrophil traps. It 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 and Phase IIa clinical study for the treatment of severe COVID-19 patients conducted in Europe, 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. The comprehensive promotion of international multi-center clinical practice demonstrates the continuous improvement of the Group’s global innovation and R&D capabilities.
The Board of Grand Pharmaceutical Group Limited, commented, “The achievement of the enrollment of patients in the Phase Ib clinical study in China and the primary clinical endpoint in the Phase IIa clinical study in Europe of STC3141 are not only important milestones 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 adhere to the strategy of ‘global expansion and dual-cycle operation’, and make full use of its industrial advantages and R&D capabilities, to accelerate commercialization process for innovative products and provide patients with more advanced and diverse treatment options in the world.”