On October 31, Broad Pharma (0512.HK) announced that its phase Ib clinical trial (NCT05000671) of STC3141, designed to treat acute respiratory distress syndrome (ARDS) in China, has successfully reached the endpoint of clinical research.
The novel mechanism of action of STC3141 and smooth global clinical progress
STC3141 is a global innovative small molecule compound with a new mechanism of action independently developed by Broad Medicine. This product can be used for multiple severe indications by neutralizing extracellular free histones and neutrophil trap nets to reverse organ damage caused by excessive immune response. Its preclinical related research results have been published in the top academic journal Nature Communications, with far-reaching academic influence and rapid clinical progress.
This NCT05000671 is a randomized, double-blind, placebo-controlled phase Ib clinical study designed to study and evaluate the safety, tolerability, and pharmacokinetic properties of STC3141 in treating patients with ARDS. According to the data analysis of the clinical trial, the overall safety characteristics did not indicate any potential serious safety problems or unexpected results in the primary endpoint of the study, and the positive signal in alleviating ARDS severity, improving ARDS patient prognosis, helping ARDS patients from ventilator and shortening ICU hospital stay, which provides a solid foundation for further clinical research of the product.
In addition to this clinical study in China, the STC3141's phase IIa clinical study in Europe to treat severe COVID-19 patients has also successfully reached the clinical endpoint earlier, with no drug-related serious adverse effects, and was well tolerated by patients. In addition, the phase Ib clinical study of this product for the treatment of sepsis was approved in Australia and Belgium in May 2020 and April 2022, respectively, and the international multi-center clinical study was comprehensively promoted.
It is noteworthy that ARDS, as one of the main causes of death in ICU patients, currently lacks effective drug treatment clinically. According to the data, the prevalence rate of ARDS in critically ill patients with ICU is about 10.4%, the overall hospital fatality rate is about 34%, and the fatality rate of severe patients is about 60%. In addition, in patients with severe COVID-19, ARDS is also one of the major causes of death, with urgent clinical needs and huge market prospects.
The clinical endpoint of the STC3141 China phase Ib clinical study is not only an important milestone in the company's global clinical research process, but also provides a solid data support for its subsequent clinical development work.
We will promote global clinical research on innovative products and consolidate the layout of critical care areas.
Respiratory and severe anti-infection plate is one of the core strategic field, the company in the sector has sold nearly 10 products, covering rhinitis, pharyngitis, bronchitis, pneumonia, and other indications, the core products chnot and golden voice series are the national exclusive varieties, including chnot in oral expectorant market hospital end and retail sales are ranked first all the year round, there are many products in the field of niche leading position. In addition, the company's two global innovative compound preparations for asthma®And Enzhuo Run®Both products, which were officially launched in China in September this year, are a new generation of compound inhalation preparations, which are expected to further improve patient compliance by giving them a once-daily dose.
Innovative products, Broad Medicine is this section for unmet clinical indications such as allergic rhinitis, sepsis, ARDS, COVID-19 and parainfluina, Four global innovative drugs are currently in reserve, Among them, Ryaltris, a new compound nasal spray used for the treatment of seasonal allergic rhinitis, has entered the registered clinical stage, Its Chinese phase III clinical study has completed the first patient enrollment in April this year; STC3141, a global innovative drug for severe diseases such as sepsis, has received seven clinical approvals in five countries, International and global multi-center clinical smooth progress; APAD, another global innovative drug that can cooperate with STC3141 to treat severe diseases such as sepsis, and the world's first new parainfluenza drug, have all completed compound screening, Entering the preclinical research phase.
In the direction of severe and anti-infection, Broad Medicine is based on the sugar-omics research and development technology platform, and the company has set up a research and development center in Australia to develop global innovative products. Broad Medicine Australia R & D Center has maintained a long-term and in-depth cooperation with Australian National University and Griffith University, Australia. The Parainaflu project is in cooperation with the inventor of Zanamivir and the director of the Sugar Group Research Institute of Griffith University, Australia. The institute is one of the few research institutes in the world focusing on sugar omics, and one of the world's largest in the field.
Broad medicine, said the company will continue to adopt the future independent research and development and global development concept, build airway slow disease full cycle management product cluster and severe anti-infection product pipeline, constantly consolidate the industry leading position in the field, and give full play to the company's industrial advantages and research and development strength, rapid science and technology innovation products listed, provide more advanced patients more diverse treatment solutions.
