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

HM12525A is a long-acting GLP-1/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 the Glucagon and GLP-1 receptors as Oxyntomodulin (OXM), 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 and suppression of food intake) and Glucagon receptor (suppression of food intake, increased energy expenditure and improved lipid metabolism) suggest that Oxyntomodulin-based therapies could provide superior efficacy in subjects with obesity.

In clinical studies of HM12525A, we observed a remarkable weight loss effect and improved lipid profile, and have prioritized clinical development as an anti-obesity medication.

  1. GLP-1/Glucagon dual agonism
    • Synergistic effects on body weight loss
    • Counteraction on glycemic control
  2. Weekly injection by application of LAPS technology
    • 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
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
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
LAPSGLP/GCG dual agonist, HM12525A, confirmed prolonged pharmacokinetics in healthy volunteers: A first-in-human phase 1 study
Oral presentation, American diabetes association (ADA) 75th Scientific sessions, 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
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
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 cholesterol lowering effect by HM12525A, A novel long-acting GLP-1/Glucagon dual receptor agonist
Poster, American diabetes association (ADA) 76th Scientific sessions, 2016
Press Releases