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.
HM15136 is a long-acting Glucagon analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY). The physiological effects of glucagon receptor agonism (suppression of food intake, increased energy expenditure, and improved lipid metabolism) suggest superior weight loss efficacy in subjects with obesity. In preclinical studies, we observed a remarkable weight loss effect and improved lipid profile.
Additionally, GCGR agonism for glucose homeostasis by increasing glycogenolysis and gluconeogenesis suggests a novel therapeutic option in patients with various chronic hypoglycemic diseases such as congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric surgery (PBS). In preclinical studies with insulin-induced hypoglycemic model, chronic treatment of HM15136 provided a stable euglycemic profile. Based on the result, HM15136 was granted FDA and EMA orphan drug designation for the treatment CHI.
A phase 1, first in human (FIH), single ascending dose (SAD) study was completed (NCT04032782), safe and tolerable profiles were confirmed in healthy subjects. We are currently conducting the phase 1b in US, Multiple ascending dose (MAD) trial of HM15136 in obese subjects with or without T2DM (NCT04167553).