CUREGENE will announce the latest clinical data of the new generation antiplatelet drug ifogrel (CG-0255) at the 2025 American Heart Association Annual Meeting
CUREGENE recently announced that the early clinical research results of its independently developed new antiplatelet drug efogrel (CG-0255) completed in China and the United States have been accepted by the 2025 American Heart Association Annual Meeting and will be officially released as a poster in November 2025 (No. 4359647). At present, cardiovascular and cerebrovascular diseases have become the leading cause of death in the world, and thrombosis is the most direct cause of cardiovascular and cerebrovascular diseases. P2Y12 receptor inhibitors are currently the core drugs for global antiplatelet treatment. However, currently only 4 drugs have been approved in the world, and only 2 drugs have been approved for marketing in China. Clopidogrel, as the most widely used P2Y12 inhibitor, has significant clinical limitations: it is deeply dependent on the conversion and activation of the liver CYP2C19 enzyme, and about 58% of the Chinese population has CYP2C19 function deficiency, resulting in "clopidogrel resistance" and the anti-platelet efficacy is weakened or even ineffective. In addition, clopidogrel has a slow onset of action and no injectable dosage form, making it difficult to fully meet the current needs for clinical emergency treatment. In response to this clinical gap, CUREGENE has developed the world's first new generation P2Y12 inhibitor with both oral and injectable dosage forms - ifogrel (CG-0255). The drug adopts an innovative sulfhydryl hydrolysis prodrug design to comprehensively change the metabolism and active conversion pathways of existing drugs, and fundamentally overcome the metabolic limitations of clopidogrel.
Outstanding advantages of ifogrel (CG-0255) • Rapid onset of action: It exerts antiplatelet effects within 15 minutes of injection and <30 minutes of oral administration, much faster than clopidogrel (about 4 hours); • Completely overcomes clopidogrel resistance: does not rely on CYP2C19 metabolism, and there is almost no individual difference in hydrolase distribution; • Strong anti-platelet effect: the platelet inhibition rate is significantly better than clopidogrel, and the dose-effect relationship is clear; •Good safety: Among the 128 subjects who have completed the test, even if the platelet inhibition rate exceeds 80%, no increase in the risk of bleeding has been observed; •High conversion efficiency: the prodrug conversion rate is more than a hundred times that of clopidogrel, 2 mg of efogrel can achieve the efficacy of 300 mg of clopidogrel, and the clinical dosage is expected to be 1/100 of the latter; •Low drug-drug interaction (DDI) risk: superior metabolic pathways, effectively avoiding interactions with a variety of chronic concomitant medications. The results of the Sino-US bridging trial show that the efficacy of ifogrel is basically the same in different ethnic groups, with no obvious racial differences. A number of clinical data have consistently shown that the drug is significantly better than existing standard drugs in terms of efficacy and safety. It not only fills the gap in acute-phase injection treatment of stroke in China, but also provides a new generation of "best-in-class" antiplatelet treatment options for patients with coronary heart disease and stroke.
About Ifosugrel (CG-0255) Ifosugrel (CG-0255) is a new generation of antiplatelet drug independently developed by CUREGENE. It is the world's first P2Y12 receptor inhibitor designed based on sulfhydryl hydrolysis prodrug technology and available in both intravenous and oral dosage forms. Its innovative molecular structure can directly release active metabolites through one-step hydrolysis, fundamentally overcoming the problem of "clopidogrel resistance" caused by the defect of CYP2C19 metabolic enzyme of clopidogrel. It has significant advantages such as rapid onset of action (intravenous injection <15 minutes, oral administration <30 minutes), strong anti-platelet efficacy, small individual differences, and low risk of drug interaction. The injection form of the drug fills the clinical gaps at home and abroad in emergency scenarios such as stroke and myocardial infarction, and has the potential to become a "best-in-class" antiplatelet therapeutic drug that meets the clinical medication needs in all scenarios. The product is currently in late-stage clinical development and is expected to be approved for marketing as early as 2027.
About CUREGENE CUREGENE was founded in 2018 and has core platform technology and efficient and independent innovation capabilities. The company currently focuses on the treatment of cardiovascular and cerebrovascular diseases and anti-viral diseases, and is committed to becoming an innovative pharmaceutical company with a global presence based in China. CUREGENE has successfully developed a number of innovative pipeline drugs with broad market value and global independent intellectual property rights based on its own platform technology, and is currently actively promoting the clinical development of multiple pipelines. Driven by the company's mission and vision, CUREGENE has gathered a group of high-level scientists and returnee talents with global perspectives. Under the company's comprehensive strategic layout, CUREGENE has successfully achieved rapid and efficient transformation of research and development results, and all pipelines under development have the potential to become First-in-Class or Best-in-Class drugs.
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