Hanmi showcases efosipegtrutide's potential for liver fibrosis at AASLD conference

Hanmi Pharmaceutical said Tuesday that it presented results from a study confirming the potential of efocipegtrutide (LAPS Triple agonist), a new drug for metabolic-associated steatohepatitis (MASH), to improve liver fibrosis directly and differentiate treatment efficacy through its glucagon activity.

The Korean company presented the study at the American Association for the Study of Liver Diseases (AASLD)’s international conference.

Efosipegtrutide is a triple-acting innovative biologic that simultaneously activates glucagon, which increases the body's energy metabolism, glucagon-like peptide-1 (GLP-1), helping to increase insulin secretion and suppress appetite, and the gastric inhibitory peptide (GIP) receptor, which stimulates insulin secretion and has anti-inflammatory properties.

In the study, Hanmi Pharmaceutical evaluated whether efosipegtrutide could show differential efficacy in improving liver inflammation and liver fibrosis through glucagon compared to other candidates (semaglutide and tirzepatide) in an animal model of induced liver inflammation and liver fibrosis.

As a result, repeated administration of efosipegtrutide reproducibly confirmed the improvement of inflammation and fibrosis in liver tissue and demonstrated differentiated therapeutic efficacy, especially through glucagon activity, which was not confirmed in other candidates.

“Based on the differentiated efficacy in improving liver fibrosis identified in nonclinical studies, efosipegtrutide will be developed as a breakthrough therapy for MASH, a disease with a high unmet medical need,” Hanmi Pharmaceutical said.

Hanmi is conducting a global phase 2b clinical trial in the U.S. and Korea to determine the efficacy, safety, and tolerability of efosipegtrutide compared to placebo in patients with biopsy-confirmed MASH with fibrosis.

In October, the Independent Data Monitoring Committee (IDMC) recommended that “all cohorts continue the treatment at all doses with no specific dose group exclusions” based on interim data from the global phase 2 study of efosipegtrutide.

In July 2020, the U.S. Food and Drug Administration (FDA) granted efosipegtrutide fast-track development designation for treating MASH. The FDA and European Medicines Agency (EMA) also granted it orphan drug designation for treating idiopathic pulmonary fibrosis (IPF), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC).

“Based on our long-standing R&D capabilities in metabolic diseases, we are continuously creating innovative possibilities in the field of MASH treatment,” said Choi In-young, head of Hanmi Pharmaceutical’s R&D Center. “Hanmi's efocipegtrutide will provide a new treatment paradigm in the global MASH market, which is expected to grow to 30 trillion won ($21.3 billion).”