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efpegerglucagon (LAPSGlucagon analog)

Rare Disease

Phase 2

Overview
Proven concept for sustained glucose elevation novel option
for preventive treatment of CHI
Efpegerglucagon is a long-acting glucagon analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker.

The main physiological effects of glucagon receptor agonism (increasing glycogenolysis and gluconeogenesis) and favorable physicochemical and PK properties suggest therapeutic potential of Efpegerglucagon in subjects with chronic hypoglycemic diseases such as congenital hyperinsulinism (CHI) and hypoglycemia post-bariatric surgery (PBH). Efpegerglucagon received orphan drug designation from the FDA, EMA, and MFDS for the treatment of CHI, and received rare pediatric disease designation from in the U.S FDA. Efpegerglucagon has also been designated as an orphan drug by the EMA for the treatment of insulin autoimmune syndrome.

Additionally, glucagon receptor agonism is also associated with increased energy expenditure and improvement of various cardiometabolic risk factors. In nonclinical studies, improved lipid profile, kidney function, and blood pressure were observed along with a remarkable weight loss effect.
Description
Glucagon receptor agonism (for chronichypoglycemic disease)
  • Sustained glycogenolysis
  • Sustained gluconeogenesis
Glucagon agonism (for obesity)
  • Body weight loss via food intake inhibition, increased energy expenditure, and lipid metabolism
  • Improved insulin resistance through weight loss (lipid profile)
Ultra-long duration of action
  • Extended duration of action by LAPSCOVERY
  • Targeting first-in-class weekly glucagon agonist
Clinical Development
Publications
Poster
Safety and efficacy of efpegerglucagon in patients with congenital hyperinsulinism: interim results from a phase 2 study
European Society for Paediatric Endocrinology (ESPE) Meeting, 2024
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Poster
In vitro characterization of a novel long-acting glucagon analog (HM15136) and its potential effect in animal models of chronic hypoglycemic diseases
Endocrine (ENDO) Society meeting, 2023
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Journal
A double-blind, placebo-controlled, single-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long-acting
Diabetes Obes Metab. 2022; 24(3): 411-420
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Journal
A novel glucagon analog with an extended half-life, HM15136, normalizes glucose levels in rodent models of congenital hyperinsulinism
Scientific Reports. 2022; 12:16765
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Presentation
Beneficial effects on metabolic disorders by a long-acting glucagon analogue, HM15136, in pre-clinical models
European association for the study of diabetes (EASD) 58th Annual meeting, 2022
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Poster
Potential Effect of a Novel Combination of GLP-1RA (efpeglenatide) and Long-Acting Glucagon Analog (HM15136) in Animal Models of Metabolic Disorders (657-P)
American diabetes association (ADA) 81st Scientific sessions, 2021
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Poster
Sustained Glucagon Effect on Cardiovascular Renal and Metabolic Disorders Mediated by a Long-Acting Glucagon Analog, HM15136, in Animal Disease Models (658-P)
American diabetes association (ADA) 81st Scientific sessions, 2021
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Poster
Potent weight loss effects and mechanism of a novel long-acting Glucagon analog, HM15136, in animal models
American diabetes association (ADA) 80th Scientific sessions, 2020
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Poster
Beneficial effects of a novel long-acting glucagon analog, HM15136, on obesity and obesity related metabolic disorders in animal models
American diabetes association (ADA) 80th Scientific sessions, 2020
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Poster
A double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long-acting glucagon analogue, in healthy subjects
American diabetes association (ADA) 80th Scientific sessions, 2020
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Poster
Sustained Glucagon effect on blood glucose and improvements of insulin resistance mediated by a novel long-acting Glucagon analogue, HM15136, in animal models
European association for the study of diabetes (EASD) 55th Annual meeting, 2019
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Poster
Potential of a novel long-acting Glucagon analogue, HM15136, for the treatment of obesity
European association for the study of diabetes (EASD) 55th Annual meeting, 2019
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Poster
Potential of a novel long-acting Glucagon analog, HM15136, for the treatment of obesity
American diabetes association (ADA) 79th Scientific sessions, 2019
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Poster
Potent weight loss mechanism by a novel long-acting Glucagon analog, HM15136, in animal models
American diabetes association (ADA) 79th Scientific sessions, 2019
Download
Poster
Sustained Glucagon effect on blood glucose and improvements of insulin resistance mediated by a novel long-acting Glucagon analog, HM15136, in animal models
American diabetes association (ADA) 79th Scientific sessions, 2019
Download
Poster
Therapeutic potential of novel combination of a long-acting Glucagon analog (HM15136) and antidiabetic drugs for the treatment of obesity
American diabetes association (ADA) 79th Scientific sessions, 2019
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Poster
A novel long-acting Glucagon analog (HM15136) offers favorable stability, PK/PD, and therapeutic potentials in CHI (congenital hyperinsulinism) animal model
European association for the study of diabetes (EASD) 53rd Annual meeting, 2017
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Poster
A novel long-acting Glucagon analog (HM15136) offers favorable stability, PK, and therapeutic potentials in congenital hyperinsulinism animal model
American diabetes association (ADA) 77th Scientific sessions, 2017
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