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/GIP/GLP-1 triple 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-R, GIP-R, and GLP1-R, 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 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. Also, HM15211 was granted FDA orphan drug designation for the treatment 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, expenditure, and lipid metabolism)
    • Improvement of liver inflammation by glucagon-mediated liver targeting
    • Direct down-regulation of hepatic stellate cell
  2. Weekly injection by application of LAPS technology
    • 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
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
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
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
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
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
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
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
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
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
Oral presentation, 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
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
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
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
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
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
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
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
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
Press Releases