▲ Clinical results of ‘Epeglenatide’ listed in the October issue of the world-renowned medical journal ‘The Lancet’. ⓒHanmi Pharm
Hanmi Pharmaceutical announced on the 18th that a meta-analysis study including global clinical results including cardiovascular safety of its new biologic drug ‘Epeglenatide’ was registered in the October issue of the world-renowned medical journal ‘The Lancet’.
Efpeglenatide is a GLP-1 diabetes treatment biologic developed by Hanmi Pharm in a once-weekly dosage form. The papers listed in The Lancet are based on the results of a large-scale global phase 3 study conducted by Sanofi, which had the right to develop efpeglenatide until 2020.
According to the published paper, Professor Navid Sata of the University of Glasgow, UK, and colleagues performed a meta-analysis of the cardiovascular benefits and risk ratios of GLP-1 receptor agonists in type 2 diabetes. The research team used clinical data of a total of 680 patients from 8 studies that met appropriate criteria, such as cardiovascular mortality assessment, in studies in which more than 500 patients were enrolled among GLP-1 related papers published until June of this year.
The research team included the clinical trial of epeglenatide AMPLITUDE-O in this study, further demonstrating the cardiovascular safety of GLP-1 drugs. It was also demonstrated that 3-point MACE (cardiovascular death, myocardial infarction, stroke) was reduced for the first time as an exendin-4 based GLP-1 receptor agonist.
The researchers found that GLP-1 receptor agonists also reduced the hospital admission rate for heart failure in diabetic patients by 11%.
The AMPLITUDE-O clinical trial was led by Sanofi and is a phase 3 clinical trial announced at the American Diabetes Association (ADA) in June.
Se-chang Kwon, president of Hanmi Pharm, said, “We will do our best to present the possibility of creating new innovations for efeglenatide, which has secured benefits such as blood sugar and blood pressure control, weight loss, and cardiovascular safety.”
