Shanghai-based Eccogene has announced receiving approval from the US FDA to initiate a Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) targeting type 2 diabetes mellitus (T2DM), in healthy participants and subjects with T2DM.
GLP-1 Mechanism and Applications
GLP-1 is a peptide secreted from gut enteroendocrine cells that modulates postprandial glycemic excursions through increased glucose-dependent insulin secretion, reduced glucagon secretion, and delayed gastric emptying. It also suppresses appetite to reduce body weight by activating GLP-1 receptors in certain areas of the brain. GLP-1 RAs have been approved for treating T2DM and obesity and are recommended as the initial therapy for T2DM patients with or at high risk for atherosclerotic cardiovascular disease or chronic kidney disease. Additionally, GLP-1 RAs are currently being studied to treat non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease. However, nearly all currently approved GLP-1 RAs require administration by subcutaneous injection.
Market Landscape
GLP-1R agonists approved for marketing in China include Bristol Myers Squibb/Eli Lilly’s Byetta (exenatide), Novo Nordisk’s Victoza (liraglutide), Benemae Pharma’s benaglutide, Sanofi’s Lyxumia (lixisenatide), AstraZeneca’s Bydureon (exenatide microspheres), Eli Lilly’s Trulicity (dulaglutide), Hasoh Pharma’s polyethylene glycol loxenatide, and Novo Nordisk’s Ozempic (semaglutide). The initiation of the Phase I study for ECC5004 highlights Eccogene’s efforts to advance innovative treatments for T2DM, potentially offering a new therapeutic option for patients.
Future Development
The FDA approval underscores Eccogene’s commitment to advancing innovative therapies for type 2 diabetes. By evaluating ECC5004 in clinical trials, Eccogene aims to further explore its potential as a novel treatment option, potentially enhancing patient outcomes and expanding treatment options in the field of diabetes management.-Fineline Info & Tech
