Hanmi Pharmaceutical said that the U.S. Food and Drug Administration has granted an orphan drug designation (ODD) to LAPS Triple Agonist based on its new indication.

Hanmi headquarters in Bangi-dong, eastern Seoul.

Hanmi’s LAPS Triple Agonist, codenamed HM15211, is a non‐alcoholic steatohepatitis (NASH) treatment candidate.

It is a therapeutic agent with multiple pharmacological effects through simultaneous stimulation of GLP-1 receptor, glucagon receptor, and GIP receptor. The company expects to develop the agent for various autoimmune liver diseases by reducing liver inflammation and fibrosis and suppressing autoimmune destruction of bile ducts

The drug candidate's additional indication is for treating primary biliary cholangitis, a chronic progressive biliary identity liver disease caused by inflammation and fibrosis of the unknown intrahepatic biliary tract. The gradual destruction of the bile ducts can lead to the obstruction of the bile ducts and damage to the liver tissue, and in some cases, may require the patient to have a liver transplant.

The additional indication came after the company received the ODD status for the drug candidate in treating sclerosing cholangitis, a chronic progressive cholestatic liver disease caused by inflammation and fibrosis of unknown intrahepatic and extrahepatic bile ducts, on March 5.

FDA's ODD system helps to facilitate the development and approval of therapeutic drugs for rare, life-threatening diseases. ODD drugs receive tax benefits, exemption of license application fees, and seven-year monopoly after obtaining authorization.

"We are pleased to demonstrate the potential of LAPS Triple Agonist in the area of autoimmune disease treatment as the result of FDA's ODD designation," Hanmi Pharmaceutical CEO Kwon Se-chang said. "Hanmi is doing a lot of research in the field of rare refractory diseases as well as metabolic and anticancer diseases and expects good results to continue.

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