- 파이프라인
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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.
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
Monthly subcutaneous
administration by
LAPSCOVERY technology
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).
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