파이프라인
한미약품은 축적된 연구 개발 기술력을 바탕으로 항암, 대사성, 심혈관 · 신장계, 희귀질환 치료제 분야에서
다양한 혁신신약을 개발하고 있습니다.

주요 파이프라인 소개

한미약품과 인류의 건강을 위한 창조와 혁신 그리고 도전 정신을 함께 할 파트너사를 찾습니다.

HM15912 (LAPSGLP-2 analog)

OVERVIEW

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, considering once a month administration.

In nonclinical 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. - HM15912 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 absorbing capacity
Monthly subcutaneous
administration by
LAPSCOVERY technology
  • 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

Anti-inflammatory and intestinotrophic effects by HM15912, a novel long-acting GLP-2 analog, in mouse model of graft-versus-host disease based on chemotherapy conditioning and MHC-mismatched transplant
Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2023
Therapeutic potential of long-acting GLP-2 analog (HM15912) in preclinical models of steroid-refractory acute graft-versus-host disease (SR-aGvHD)
Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2023
Beneficial effect on intestinal growth of a long-acting GLP-2 analog, HM15912, after treatment switching from conventional GLP-2 drug or other long-acting GLP-2 analogs under clinical development in animal model
Poster, Endocrine (ENDO) Society meeting, 2023
HM15912, a novel long-acting GLP-2 analog, improves intestinal growth and absorption capacity in rat model of short bowel syndrome
Poster, Endocrine (ENDO) Society meeting, 2023
An ongoing phase 2 study of HM15912, a novel long-acting glucagon-like peptide 2 (GLP-2) analog for short bowel syndrome-intestinal failure (SBS-IF) patients
Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2022
Intestinal hypertrophic and Anti-inflammatory potential of a Novel Combination of Long-acting GLP-2 analog (HM15912) and GLP-1RA (efpeglenatide) in Animal model of Inflammatory Bowel Disease
Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2022
Pharmacological benefits of multifaceted mode of action for a novel combination of long-acting GLP-2 analog (HM15912) and GLP-1RA (efpeglenatide) in animal model of inflammatory bowel disease
Oral Presentation, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2022
Intestinotrophic Effect of A Novel Long-acting GLP-2 Analog, HM15912, in Animal Model for Short Bowel Syndrome and Potential as Monthly Administration
Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2021
Beneficial Effects of a Long-acting GLP-2 Analog, HM15912, After Switching from Daily or Weekly GLP-2 Analog Drugs in Animal Model
Oral Presentation, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2021
A First-in-Human, Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Subjects
Poster, The American Society for Parenteral and Enteral Nutrition (ASPEN), 2021
Intestinotrophic Effect of A Novel Long-acting GLP-2 Analog, HM15912, in Animal Model for Short Bowel Syndrome and Potential as Monthly Administration
Oral Presentation, ASPEN Nutrition Science & Practice Conference (ASPEN), 2021
Beneficial Effects of A Long-acting GLP-2 Analog, HM15912, After Switching from Daily or Weekly GLP-2 Analog Drugs in Animal Model
Poster, ASPEN Nutrition Science & Practice Conference (ASPEN), 2021