R&D

Pipeline

The hero of the global First-in Class is Hanmi Pharmaceutical.
Hanmi Pharmaceutical is developing in the areas of anti-cancer,
obesity, diabetes, and rare diseases.

Focused Pipeline

Overview

Efinopegdutide(LAPSGLP/GCG) is a long-acting glucagon-like peptide 1 and glucagon dual agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY). A dual GLP-1/glucagon agonist activates both GLP-1 and glucagon receptors as oxyntomodulin, which is an endogenous peptide secreted by cells in the gut in response to nutrient ingestion.

The physiological effects mediated by GLP-1 receptor (enhanced glucose-stimulated insulin secretion, suppression of food intake, and regulation of inflammatory cytokines in liver) and glucagon receptor (suppression of food intake, increased energy expenditure, improved lipid metabolism, and regulation of inflammatory cytokines in liver) suggest a therapeutic potential in subjects with obesity and/or non-alcoholic steatohepatitis (NASH).

In clinical studies, we observed a remarkable weight loss effect with improved lipid profile and several metabolic phenotypes such as cardiovascular and renal function. Furthermore, in preclinical studies, glucagon action on liver such as liver fat burning and improvement in inflammation was recently revealed and these may suggest additional benefits for liver health such as non-alcoholic fatty liver disease (NAFLD) and NASH. Based on this, Hanmi and the licensed partner, MSD, are set to expand the clinical development for NASH besides obesity.

  1. GLP-1/Glucagon dual agonism
    • Remarkable body weight loss via synergistic effects of GLP-1 and glucagon
    • Counteraction on glycemic control
    • Liver fat removal by three combined mode of action (energy intake, β-oxidation, and de novo lipogenesis) and Improvement of liver inflammation
  2. Weekly injection by application of LAPS technology
    • Extended duration of action via vascular endothelium recycling without effector functions (ADCC and CDC)
    • Targeting first-in-class weekly GLP-1/glucagon dual agonist

Clinical Development

Clinical experience with HM12525A includes two phase 1 multiple ascending dose (MAD) studies (NCT02862431 and NCT03235219). Additional four phase 1 studies was completed to assess the effect of HM12525A of titration (NCT03586843) and on cardiac repolarization (NCT03606057) and on PK and safety in subjects with varying degrees of renal function (NCT03546205), and on PK and safety in japanese subjects (NCT03618160). Two phase 2 studies was completed to evaluate safety and efficacy of HM12525A in severe obese patients without or with T2DM (NCT03486392 and NCT03586830).

Publications
Potent cholesterol lowering effect by HM12525A, A novel long-acting GLP-1/Glucagon dual receptor agonist
Poster, American diabetes association (ADA) 76th Scientific sessions, 2016
The ultra-long acting LAPSGLP/GCG dual agonist, HM12525A, demonstrated safety and prolonged pharmacokinetics in healthy volunteers: a phase 1 first-in-human study
Poster, European association for the study of diabetes (EASD) 51st Annual meeting, 2015
Potent weight loss mechanism and improvement of NASH by the long-acting GLP-1/Glucagon receptor dual agonist HM12525A
Poster, European association for the study of diabetes (EASD) 51st Annual meeting, 2015
A novel long-acting GLP-1/Glucagon dual receptor agonist: Potent weight loss mechanism and improvement of NASH by HM12525A
Poster, American diabetes association (ADA) 75th Scientific sessions, 2015
Lipolytic, energy expenditure, and insulinotropic effects of HM12525A: A novel long‐acting GLP‐1/Glucagon dual agonist
Poster, American diabetes association (ADA) 74th Scientific sessions, 2014
Poster, European association for the study of diabetes (EASD) 50th Annual meeting, 2014
The novel long-acting GLP-1/Glucagon dual agonist HM12525A reduces body weight and improves glycemic control in rodent models
Poster, American diabetes association (ADA) 73rd Scientific sessions, 2013
Press Releases