An international medical journal published the meta-analysis of studies, including the cardiovascular safety trial of Hanmi Pharmaceutical’s investigational antidiabetic drug, efpeglenatide.
Industry watchers are paying attention to whether the publication will be a turning point for the development of efpeglenatide, especially after Sanofi returned the development right to Hanmi last year.
Hanmi said on Monday that the October issue of The Lancet Diabetes & Endocrinology published the meta-analysis of trials that included the company’s study of its new biologic drug efpeglenatide.
Efpeglenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that can be injected once per week.
The Lancet’s paper included the global phase 3 AMPLITUDE-O trial results that Sanofi had conducted until 2020 with the efpeglenatide development right.
In June, Sanofi released the results of the global phase 3 trial of efpeglenatide at the meeting of the American Diabetes Association (ADA).
The trial involved 4,076 patients with type-2 diabetes or cardiovascular disease across 344 regions in 28 countries. Sanofi injected 4mg or 6mg of efpeglenatide monotherapy or a placebo weekly.
The efpeglenatide-treated group had a 27 percent reduction in major cardiovascular diseases, and a 32 percent drop in kidney disease, compared to the placebo group.
According to the paper in the Lancet, the research team led by professor Naveed Sattar at the University of Glasgow, the U.K., did a meta-analysis to estimate cardiovascular benefits of GLP-1 receptor agonists and overall hazard ratios (HRs) in type-2 diabetes.
The research team used clinical data of 60,080 patients from eight studies that met appropriate criteria, such as cardiovascular mortality assessment, among studies of more than 500 patients among GLP-1 related papers published up to June 2021.
According to Hanmi, the research team not only confirmed GLP-1 receptor agonists’ cardiovascular safety additionally but proved to reduce “3-point MACE” (cardiovascular death, myocardial infarction, or stroke) as the first exendin-4-based GLP-1 receptor agonists.
Also, the research team found that GLP-1 receptor agonists lowered hospital admission for heart failure by 11 percent, which was statistically significant.
The paper showed that the effect of once-weekly GLP-1 receptor agonists, including efpeglenatide, was almost the same as that of daily injections.
Hanmi Pharmaceutical CEO Kwon Se-chang said it was meaningful that efpeglenatide, one of the commonly used GLP-1 receptor agonists worldwide, contributed to the favorable outcome of the meta-analysis study.
“We will do our best to present the new innovative potential of efpeglenatide, which secured benefits such as blood sugar and blood pressure control, weight loss, and even cardiovascular safety,” he said.