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.
Efinopegdutide(LAPSGLP/GCG) is a long-acting glucagon-like peptide 1 and 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 GLP-1 and glucagon receptors as oxyntomodulin, 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, suppression of food intake, and regulation of inflammatory cytokines in liver) and glucagon receptor (suppression of food intake, increased energy expenditure, improved lipid metabolism, and regulation of inflammatory cytokines in liver) suggest a therapeutic potential in subjects with obesity and/or non-alcoholic steatohepatitis (NASH).
In clinical studies, we observed a remarkable weight loss effect with improved lipid profile and several metabolic phenotypes such as cardiovascular and renal function. Furthermore, in preclinical studies, glucagon action on liver such as liver fat burning and improvement in inflammation was recently revealed and these may suggest additional benefits for liver health such as non-alcoholic fatty liver disease (NAFLD) and NASH. Based on this, Hanmi and the licensed partner, MSD, are set to expand the clinical development for NASH besides obesity.
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).