The hero of the global First-in Class is Hanmi
Hanmi Pharmaceutical is developing in the areas of anti-cancer,
obesity, diabetes, and rare diseases.
HM12525A is a long-acting GLP-1/Glucagon dual agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY). A dual GLP-1/Glucagon agonist activates both the Glucagon and GLP-1 receptors as Oxyntomodulin (OXM), which is an endogenous peptide secreted by cells in the gut in response to nutrient ingestion
The physiological effects mediated by GLP-1 receptor (enhanced glucose-stimulated insulin secretion and suppression of food intake) and Glucagon receptor (suppression of food intake, increased energy expenditure and improved lipid metabolism) suggest that Oxyntomodulin-based therapies could provide superior efficacy in subjects with obesity.
In clinical studies of HM12525A, we observed a remarkable weight loss effect and improved lipid profile, and have prioritized clinical development as an anti-obesity medication.
Clinical experience with HM12525A includes two phase 1 multiple ascending dose (MAD) studies (NCT02862431 and NCT03235219). Additional four phase 1 studies was completed to assess the effect of HM12525A of titration (NCT03586843) and on cardiac repolarization (NCT03606057) and on PK and safety in subjects with varying degrees of renal function (NCT03546205), and on PK and safety in japanese subjects (NCT03618160). Two phase 2 studies was completed to evaluate safety and efficacy of HM12525A in severe obese patients without or with T2DM (NCT03486392 and NCT03586830).