- 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.
efocipegtrutide (LAPSTriple agonist)
OVERVIEW
Efocipegtrutide is a long-acting glucagon, gastric inhibitory peptide (GIP) and glucagon-like peptide-1 (GLP-1) triple full agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker
(LAPSCOVERY)
The physiological effects mediated by optimal activation of multiple incretin receptors, Glucagon, GIP, and GLP-1 receptors, could provide an improved therapeutic efficacy in subjects with non-alcoholic steatohepatitis (NASH) and fibrosis compared to any single targeting medications via simultaneously affecting liver fat accumulation, inflammation, and fibrogenesis - the hallmark of NASH.
In nonclinical studies, remarkable reduction in liver fat content and robust improvement in liver inflammation and fibrosis were observed in various animal models of NASH and/or liver fibrosis. Based on these results, we prioritized clinical development of efocipegtrutide as a novel therapeutic medication for NASH/fibrosis. Recently, phase 2b clinical study is being investigated in biopsy-confirmed NASH subjects with fibrosis. The FDA granted fast track designation to efocipegtrutide for the treatment of NASH.
In addition, potential benefit in diverse fibrotic diseases of high unmet medical needs is being investigated for efocipegtrutide’s indication expansion. Based on promising nonclinical study results, efocipegtrutide received orphan drug designation from the FDA and EMA for the treatment of idiopathic pulmonary fibrosis (IPF), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC).
The physiological effects mediated by optimal activation of multiple incretin receptors, Glucagon, GIP, and GLP-1 receptors, could provide an improved therapeutic efficacy in subjects with non-alcoholic steatohepatitis (NASH) and fibrosis compared to any single targeting medications via simultaneously affecting liver fat accumulation, inflammation, and fibrogenesis - the hallmark of NASH.
In nonclinical studies, remarkable reduction in liver fat content and robust improvement in liver inflammation and fibrosis were observed in various animal models of NASH and/or liver fibrosis. Based on these results, we prioritized clinical development of efocipegtrutide as a novel therapeutic medication for NASH/fibrosis. Recently, phase 2b clinical study is being investigated in biopsy-confirmed NASH subjects with fibrosis. The FDA granted fast track designation to efocipegtrutide for the treatment of NASH.
In addition, potential benefit in diverse fibrotic diseases of high unmet medical needs is being investigated for efocipegtrutide’s indication expansion. Based on promising nonclinical study results, efocipegtrutide received orphan drug designation from the FDA and EMA for the treatment of idiopathic pulmonary fibrosis (IPF), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC).
Glucagon/GIP/
GLP-1 triple agonism
Ultra-long duration of action
CLINICAL DEVELOPMENT
A phase 1 and 2a study was completed (NCT03374241, NCT03744182).
A phase 2b study with biopsy-confirmed NASH subjects are currently ongoing in US and Korea (NCT04505436).
A phase 2b study with biopsy-confirmed NASH subjects are currently ongoing in US and Korea (NCT04505436).
PUBLICATIONS
- Anti-fibrotic and mortality reduction potential of a novel long-acting glucagon/GIP/GLP-1 triple agonist (HM15211) in preclinical models of idiopathic pulmonary fibrosis
- Poster, American Thoracic Society (ATS) International conference, 2023
- Anti-inflammatory and anti-fibrotic effects of a novel long-acting Glucagon/GIP/GLP-1 triple agonist, HM15211, in TAA induced mouse model of liver injury and fibrosis
- Oral presentation, European association for the study of diabetes (EASD) 58th Annual meeting, 2022
- Anti-fibrotic potential of a novel long-acting Glucagon/GIP/GLP-1 triple agonist (HM15211) in preclinical models of idiopathic pulmonary fibrosis
- Oral presentation, European association for the study of diabetes (EASD) 58th Annual meeting, 2022
- Direct Anti-inflammatory and Anti-fibrotic Effects of a Novel Long-acting Glucagon/GIP/GLP-1 Triple Agonist, HM15211, in TAA-induced Mouse Model of Liver Injuary and Fibrosis
- Poster, American diabetes association (ADA) 82nd Scientific sessions, 2022
- Anti-fibrotic potential of a novel long-acting Glucagon/GIP/GLP-1 triple agonist (HM15211) in preclinical models of fibrosis
- Poster, American diabetes association (ADA) 81st Scientific sessions, 2021
- Multi-target engagement effect of a novel long-acting Glucagon/GIP/GLP-1 triple agonist (HM15211) in animal model of NASH
- Oral presentation, European association for the study of diabetes (EASD) 57th Annual meeting, 2021
- Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211)in CDHFD-induced NASH and fibrosis mice
- Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
- HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist, exhibits anti-inflammatory and –fibrotic effects in AMLN/TAA induced liver inflammation and fibrosis mice
- Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
- Anti-fibrotic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in BDL-induced liver fibrosis mice
- Poster, American diabetes association (ADA) 80th Scientific sessions, 2020
- Effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a NASH and liver fibrosis animal models
- Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
- Effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a dyslipidemia animal models
- Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
- Neuroprotective effects of HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
- Poster, European association for the study of diabetes (EASD) 55th Annual meeting, 2019
- A double-blinded, placebo controlled, single ascending dose study for safety, tolerability, pharmacokinetics, and pharmacodynamics after subcutaneous administration of novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in healthy obese subjects
- Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
- Effect of HM15211, a novel long-Acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
- Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
- Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a dyslipidemia animal model
- Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
- Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a NASH and fibrosis animal model
- Poster, American diabetes association (ADA) 79th Scientific sessions, 2019
- Novel combination of GLP-1/GIP/Glucagon triple agonist (HM15211) and once-weekly basal insulin offers improved glucose lowering and weight loss in a diabetic animal model
- Poster, European association for the study of diabetes (EASD) 54th Annual meeting, 2018
- Bone protective effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in the obese-osteoporosis rodent model
- Poster, European association for the study of diabetes (EASD) 54th Annual meeting, 2018
- Neuroprotective effects of HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
- Oral presentation, European association for the study of diabetes (EASD) 54th Annual meeting, 2018
- Therapeutic effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in NASH and fibrosis animal models
- Oral presentation, American diabetes association (ADA) 78th Scientific sessions, 2018
- Neuroprotective effects of HM15211, a novel long-acting GLP-1/GIP/Glucagon triple agonist in the neurodegenerative disease models
- Poster, American diabetes association (ADA) 78th Scientific sessions, 2018
- Effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in a NASH and fibrosis animal model
- Poster, American diabetes association (ADA) 78th Scientific sessions, 2018
- Bone protective effect of a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) in an animal model
- Poster, American diabetes association (ADA) 78th Scientific sessions, 2018
- Novel combination of a long-acting GLP-1/GIP/Glucagon triple agonist (HM15211) and once-weekly basal insulin (HM12460A) offers improved glucose lowering and weight loss in a diabetic animal model
- Oral presentation, American diabetes association (ADA) 78th Scientific sessions, 2018
- Neuroprotective effects of HM15211, a novel long-acting GLP-1/Glucagon/GIP tri-agonist in the MPTP Parkinson's disease mouse model
- Poster, European association for the study of diabetes (EASD) 53rd Annual meeting, 2017
- Potent body weight loss, and therapeutic efficacy in a NASH animal model by a novel long-acting GLP-1/GIP/Glucagon triple agonist (HM15211)
- Oral presentation, European association for the study of diabetes (EASD) 53rd Annual meeting, 2017
- Potent body weight loss and efficacy in a NASH animal model by a novel long-acting GLP-1/Glucagon/GIP triple-agonist (HM15211)
- Poster, American diabetes association (ADA) 77th Scientific sessions, 2017
- Neuroprotective effects of HM15211, a novel long-acting GLP-1/Glucagon/GIP triple agonist in the MPTP Parkinson's disease mouse model
- Poster, American diabetes association (ADA) 77th Scientific sessions, 2017