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.
HM15211 is a long-acting glucagon receptors, gastric inhibitory peptide and glucagon-like peptide 1 (Glucagon/GIP/GLP-1) triple full agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY).
The physiological effects mediated by activation of multiple incretin receptors, Glucagon, gip, and glp-1 receptors, could provide a novel therapeutic efficacy in patients with non-alcoholic steatohepatitis (NASH) and fibrosis compared to any single targeting medications via simultaneously improving liver fat accumulation, inflammation, and fibrogenesis - the key features of NASH and fibrosis.
In preclinical studies, we observed a remarkable reduction in liver fat content and improvement in inflammation as well as fibrosis markers in liver. Based on these observations, we prioritized clinical development as novel therapeutic medication for NASH/fibrosis. The FDA granted fast track designation to HM15211 for treatment of non-alcoolic steatohepatitis (NASH). And also, it was granted FDA orphan drug designation for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).
A phase 1, first-in-human (FIH), single ascending dose (SAD) study was completed (NCT03374241), safe and tolerable profiles were confirmed in healthy obese subjects. We are currently conducting the phase 1b/2a in US, multiple ascending dose (MAD) trial of HM15211 in obese subjects with NAFLD (NCT03744182).