Korea-US 'Raps Triple Agonist' Shows Potential for Treating Various Liver Diseases

[Asia Economy Reporter Chunhee Lee] Hanmi Pharmaceutical announced research results confirming the potential of the innovative NASH (non-alcoholic steatohepatitis) treatment drug candidate LAPS Triple Agonist (HM15211) to treat various rare liver diseases.

Hanmi Pharmaceutical revealed on the 24th that it presented three research findings on the therapeutic effects and mechanisms of LAPS Triple Agonist for NASH and rare liver diseases at the European Association for the Study of the Liver (EASL), held online over four days from the 23rd to the 26th.

LAPS Triple Agonist is a triple-acting biopharmaceutical candidate that simultaneously activates glucagon, which increases energy metabolism in the body; GLP-1, which aids insulin secretion and appetite suppression; and GIP receptors, which promote insulin secretion and have anti-inflammatory effects.

At this academic conference, Hanmi Pharmaceutical disclosed evidence of the therapeutic effects of LAPS Triple Agonist, which was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) last year for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).

According to the study, improvements were confirmed in all liver fibrosis markers measured after administering LAPS Triple Agonist to PSC and PBC models. Hanmi Pharmaceutical explained, "The efficacy was superior to the competing drug obeticholic acid." Additionally, histological liver markers such as portal vein inflammation and tissue necrosis rates were significantly reduced.

Further research newly identified a mechanism by which LAPS Triple Agonist regulates bile acid production in the liver, in addition to the previously confirmed direct anti-inflammatory and anti-fibrotic effects. A Hanmi Pharmaceutical official stated, "Through this study, we confirmed the potential for LAPS Triple Agonist to be developed as a treatment for rare liver diseases following NASH."

In two subsequent presentations, Hanmi Pharmaceutical compared the therapeutic efficacy of LAPS Triple Agonist in NASH and liver fibrosis induction models with various incretin mimetics (GLP-1, GLP-1/GIP, GLP-GCG). The study reported that LAPS Triple Agonist demonstrated differentiated efficacy in both NASH and liver fibrosis compared to existing incretin mimetics.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "We presented studies confirming the possibility and potential to expand the indications of LAPS Triple Agonist, currently being developed as an innovative NASH treatment drug, to various liver diseases with no existing treatments. We will maximize the advantage of being the fastest-developed triple-acting biopharmaceutical worldwide to create new innovations not only in rare liver diseases but also in inflammation and fibrosis."

LAPS Triple Agonist was designated as a fast track for accelerated development by the FDA in July last year. Currently, a Phase 2 clinical trial is underway in the U.S. to confirm therapeutic efficacy in NASH patients diagnosed via biopsy.