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.
HM15912 is a long-acting glucagon-like peptide 2 (GLP-2) analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY). Since GLP-2 was firstly discovered in 1996, it was approved in 2012 to treat short bowel syndrome (SBS) because of its therapeutic functions related to intestinal growth. Many patients with SBS are dependent on frequent and time-consuming intravenous supplement of nutrition, associated with serious and life-threatening complications. Although GLP-2 medication has long been used to reduce parenteral nutrition (PN) dependency, its daily administration was to be an additional treatment burden. Here, we developed the next-generation, long-acting GLP-2 analog, suitable for once a month administration.
In pre-clinical studies, we observed a remarkable intestinal growth in animal model of short bowel syndrome. In additional rodent model, HM15912 achieved significantly improved intestinal growth and absorption capacity after switching from conventional daily GLP-2 therapy. In clinical studies, we observed an extended pharmacokinetics profile in healthy subjects with safety and tolerability. Citrulline profile, which is sole biomarker for enterocyte mass, is also supporting once-a-month administration. Based on these observations, we are initiating a phase 2 study in U.S in the first half of 2021. Furthermore, HM15912 was granted orphan drug designation in both US and EU for the treatment of SBS, as well as rare pediatric disease and fast track designations in US
A phase 1, first in human (FIH), single ascending dose (SAD) study was completed (NCT04076293), where safe and tolerable profiles of HM15912 were confirmed in healthy subjects. We are currently conducting a phase 2 study in US and EU, a proof-of-concept (PoC) trial of HM15912 in adult subjects with SBS-associated intestinal failure (NCT04775706).