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/GIP/GLP-1 triple 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-R, GIP-R, and GLP1-R, 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 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. Also, HM15211 was granted FDA orphan drug designation for the treatment 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).