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

HM15211 is a long-acting glucagon receptors, gastric inhibitory peptide and glucagon-like peptide 1 (Glucagon/GIP/GLP-1) triple full agonist chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY).

The physiological effects mediated by activation of multiple incretin receptors, Glucagon, gip, and glp-1 receptors, could provide a novel therapeutic efficacy in patients with non-alcoholic steatohepatitis (NASH) and fibrosis compared to any single targeting medications via simultaneously improving liver fat accumulation, inflammation, and fibrogenesis - the key features of NASH and fibrosis.

In preclinical studies, we observed a remarkable reduction in liver fat content and improvement in inflammation as well as fibrosis markers in liver. Based on these observations, we prioritized clinical development as novel therapeutic medication for NASH/fibrosis. The FDA granted fast track designation to HM15211 for treatment of non-alcoolic steatohepatitis (NASH). And also, it was granted FDA orphan drug designation for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).

  1. Glucagon/GIP/GLP-1 triple agonism
    • Maximal efficacy for liver fat removal by three combined mode of action (energy intake, β-oxidation, and de novo lipogenesis)
    • Maximal efficacy for Improvement of liver inflammation by multiple incretin action in cooperation with favorable liver targeting
    • Direct down-regulation of hepatic stellate cell activation
  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 Glucagon/GIP/GLP-1 triple agonist

Clinical Development

A phase 1, first-in-human (FIH), single ascending dose (SAD) study was completed (NCT03374241), safe and tolerable profiles were confirmed in healthy obese subjects. We are currently conducting the phase 1b/2a in US, multiple ascending dose (MAD) trial of HM15211 in obese subjects with NAFLD (NCT03744182).

Publications
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
Press Releases
FDA grants fast track designation for Hanmi LAPSTriple Agonist
Hanmi’s anti-NASH drug candidate set to become ‘game changer’ in global pharmaceutical market
[38th J.P. Morgan healthcare conference] Hanmi, ready to lead global pharmaceutical market with innovative R&D pipeline
Hanmi proves global competiveness for obesity, diabetes, NASH treatment
“Evolution of LAPSCOVERY”…Apply to diabetes, obesity, NASH and rare disease
[36th J.P. Morgan healthcare conference] Hanmi seeks global expansion with innovative drugs for NASH, rare diseases and targeted anti-cancer drugs