Hanmi R&D becomes stronger through cooperation with partners.
- efocipegtrutide (LAPSTriple agonist)
- sonefpeglutide (LAPSGLP-2 analog)
- efpegerglucagon (LAPSGlucagon analog)
- HM97662 (EZH1/2 inhibitor)
- BH3120 (PD-L1/4-1BB BsAb)
- HM15275 (LA-GLP/GIP/GCG)
- HM16390 (LAPSIL-2 analog)
- HM17321 (LA-UCN2)
- HM99462 (SOS1 inhibitor)
- LAPS Glucagon Combo
sonefpeglutide (LAPSGLP-2 analog)
Rare Disease
Phase 2
Overview
First ‘once-a-month’ injection offering, medical and quality of life benefits
Description
sonefpeglutide is a long-acting glucagon-like peptide 2 (GLP-2) analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker.
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, considering once a month administration. In nonclinical studies, we observed remarkable intestinal growth in animal models with short bowel syndrome.
In additional rodent models, sonefpeglutide achieved significantly improved intestinal growth and absorption capacity after switching from conventional daily GLP-2 therapy. - sonefpeglutide received orphan drug designation in the FDA, EMA, and MFDS, and rare pediatric disease in the FDA. The FDA granted fast track designation for treatment of SBS-IF.
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, considering once a month administration. In nonclinical studies, we observed remarkable intestinal growth in animal models with short bowel syndrome.
In additional rodent models, sonefpeglutide achieved significantly improved intestinal growth and absorption capacity after switching from conventional daily GLP-2 therapy. - sonefpeglutide received orphan drug designation in the FDA, EMA, and MFDS, and rare pediatric disease in the FDA. The FDA granted fast track designation for treatment of SBS-IF.
GLP-2 agonism
- Increase of remnant intestinal growth and absorption capacity
- First monthly GLP-2 medication
- Patient preference and adherence via ready-to-inject with soluble formation (stable in aqueous condition)
Clinical Development
- A phase 1 study was completed NCT04076293
- A phase 2 study (DOLPHINS-2) is ongoing for the SBS with intestinal failure with stoma patients in the U.S, EU and Korea NCT04775706 EudraCT 2021-000176-11
Publications