Hanmi Pharm "New Drug Substance 'Eposipegtrutide' Confirmed to Improve Liver Fibrosis"

Research Findings Presented at the American Interdisciplinary Conference

Hanmi Pharmaceutical announced on the 15th that research results confirming the direct liver fibrosis improvement efficacy of 'Eposipegtrutide,' an innovative new drug under development, were presented at the American Association for the Study of Liver Diseases (AASLD).

Kim Jung-guk, a researcher at Hanmi Pharmaceutical R&D Center (left), is explaining the liver fibrosis improvement efficacy of epocifegtrutide, a new drug under development for MASH treatment, at the American Association for the Study of Liver Diseases (AASLD) international conference held in Boston, USA, on the 11th (local time).
[Photo by Hanmi Pharmaceutical]

Eposipegtrutide is a triple agonist bio-drug that activates all three receptors: glucagon-like peptide (GLP)-1 receptor, glucagon receptor, and glucose-dependent insulinotropic polypeptide (GIP) receptor. Based on its multi-pharmacological effects, it is expected to improve complex symptoms such as fatty liver, liver inflammation, and liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH).

The research results were presented at the AASLD international conference held in Boston, USA, from the 10th to the 14th (local time).

In this study, Hanmi Pharmaceutical compared the direct anti-inflammatory and anti-fibrotic effects of Eposipegtrutide with incretin analogs (GLP-1, GLP-1/GIP) in models induced with liver inflammation and fibrosis. As a result, the repeated administration of Eposipegtrutide reproducibly confirmed improvements in inflammation and fibrosis in liver tissue. Notably, it demonstrated superior efficacy in improving liver fibrosis compared to other incretin analogs.

A Hanmi Pharmaceutical official stated, "Although various therapeutic candidates are currently in clinical development and filing stages, they have not shown clear effects in improving liver fibrosis. We expect that Eposipegtrutide can be developed as an innovative therapeutic agent that overcomes these limitations."

Hanmi Pharmaceutical is currently conducting a Phase 2b clinical trial in the United States and Korea to confirm the therapeutic efficacy, safety, and tolerability of Eposipegtrutide compared to placebo in MASH patients with fibrosis confirmed by liver biopsy.

Eposipegtrutide's development is progressing smoothly, having recently received a recommendation from the Independent Data Monitoring Committee (IDMC) to "continue without protocol modification" based on interim results from the ongoing global Phase 2 clinical trial this year.

A Hanmi Pharmaceutical representative said, "MASH, whose incidence is increasing due to various causes such as Westernized diets regardless of alcohol consumption, not only lacks effective treatments but also has a high unmet medical need because most drugs under development show minimal efficacy in improving liver fibrosis. We will accelerate clinical development by consolidating Hanmi’s research and development (R&D) capabilities to reach commercialization as early as possible."

Meanwhile, at this conference, two additional analysis results from the Phase 2a clinical trial of another MASH treatment, 'Epinofegdutide,' which Hanmi Pharmaceutical licensed to MSD in 2020 for over 1 trillion KRW, were disclosed via posters. In MSD’s study, Epinofegdutide showed superior fatty liver improvement efficacy compared to the comparator drug semaglutide, regardless of patients’ backgrounds or ethnicity.

This content was produced with the assistance of AI translation services.