Hanmi Pharmaceutical said Thursday that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to its LAPSTriple Agonist (HM15211), a new drug for non-alcoholic steatohepatitis (NASH),.

FDA gives the fast-track designation when a treatment shows excellent therapeutic efficacy in severe or life-threatening diseases and deemed to be developed quickly after careful examination, according to the company.

HM15211 is a triple-acting agent that can overcome the limits of a single targeted oral treatment. It is a first-in-class drug applied with “Labscovery,” which is a proprietary technology platform of Hanmi Pharmaceutical, it noted.

One of the components of HM15211, glucagon, directly reduces fatty liver and inhibits fibrosis. Along with glucagon, glucagon-like peptide-1 (GLP-1) helps control appetite and insulin secretion, and gastric inhibitory peptide (GIP) acts as insulin secretion and anti-inflammatory.

Global pharmaceuticals recently faced unsuccessful outcomes in the clinical development stage because they could not prove an apparent therapeutic effect on NASH due to the complex nature of the disease.

Hanmi Pharmaceutical confirmed a significant fat reduction in non-alcoholic fatty liver disease (NAFLD) patients with obesity with a magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Most patients treated with HM15211 showed more than 50 percent reduction of the fatty liver within three months. Rapid and potent effects were also observed in fatty acid biosynthesis and beta-oxidation.

The potent anti-inflammatory and anti-fibrotic effects were also confirmed by administering HM15211 to the primary biliary and sclerosing cholangitis model induced by surgery.

“We believe HM15211 is the most advanced first-in-class drug for NASH treatment,” Hanmi Pharmaceutical CEO Kwon Se-chang said. “FDA’s Fast Track designation accelerated the study and commercialization of HM15211, and we will do our best for the development.”