Hanmi

HM15912 is a long-acting glucagon-like peptide 2 (GLP-2) analog chemically conjugated with constant region of human immunoglobulin via non-peptidyl flexible linker (LAPSCOVERY). Since GLP-2 was firstly discovered in 1996, it was approved in 2012 to treat short bowel syndrome (SBS) because of its therapeutic functions related to intestinal growth. Many patients with SBS are dependent on frequent and time-consuming intravenous supplement of nutrition, associated with serious and life-threatening complications. Although GLP-2 medication has long been used to reduce parenteral nutrition (PN) dependency, its daily administration was to be an additional treatment burden. Here, we developed the next-generation, long-acting GLP-2 analog, considering once a month administration.

In nonclinical studies, we observed a remarkable intestinal growth in animal model of short bowel syndrome. In additional rodent model, HM15912 achieved significantly improved intestinal growth and absorption capacity after switching from conventional daily GLP-2 therapy. - HM15912 received orphan drug designation in the FDA, EMA, and MFDS, and rare pediatric disease in the FDA. The FDA granted fast track designation for treatment of SBS-IF.

• Increase of remnant intestinal growth and absorbing capacity

• First monthly GLP-2 medication
• Patient preference and adherence via ready-to-inject with soluble formation (stable in aqueous condition)

A phase 1 study was completed (NCT04076293).
A phase 2 study (DOLPHINS-2) is ongoing for the SBS with intestinal failure with stoma patients in the U.S, EU and Korea (NCT04775706, EudraCT 2021-000176-11).

An ongoing phase 2 study of HM15912, a novel long-acting glucagon-like peptide 2 (GLP-2) analog for short bowel syndrome-intestinal failure (SBS-IF) patients

Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2022

Intestinal hypertrophic and Anti-inflammatory potential of a Novel Combination of Long-acting GLP-2 analog (HM15912) and GLP-1RA (efpeglenatide) in Animal model of Inflammatory Bowel Disease

Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2022

Pharmacological benefits of multifaceted mode of action for a novel combination of long-acting GLP-2 analog (HM15912) and GLP-1RA (efpeglenatide) in animal model of inflammatory bowel disease

Oral Presentation, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2022

Intestinotrophic Effect of A Novel Long-acting GLP-2 Analog, HM15912, in Animal Model for Short Bowel Syndrome and Potential as Monthly Administration

Poster, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2021

Beneficial Effects of a Long-acting GLP-2 Analog, HM15912, After Switching from Daily or Weekly GLP-2 Analog Drugs in Animal Model

Oral Presentation, The European Society for Clinical Nutrition and Metabolism (ESPEN), 2021

A First-in-Human, Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Subjects

Poster, The American Society for Parenteral and Enteral Nutrition (ASPEN), 2021

Intestinotrophic Effect of A Novel Long-acting GLP-2 Analog, HM15912, in Animal Model for Short Bowel Syndrome and Potential as Monthly Administration

Oral Presentation, ASPEN Nutrition Science & Practice Conference (ASPEN), 2021

Beneficial Effects of A Long-acting GLP-2 Analog, HM15912, After Switching from Daily or Weekly GLP-2 Analog Drugs in Animal Model

Poster, ASPEN Nutrition Science & Practice Conference (ASPEN), 2021

Jan 19, 2021

Hanmi Pharmaceutical expects U.S. FDA approval for 2 new drugs

Jan 16, 2020

[38th J.P. Morgan Healthcare Conference] Hanmi, ready to lead global pharmaceutical market with innovative R&D pipeline

Jan 15, 2018

Hanmi seeks global expansion with innovative drugs for NASH, rare diseases and targeted anti-cancer drugs