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 is developing LAPS Triple Agonist, codenamed HM15211, as non‐alcoholic steatohepatitis (NASH) treatment candidate.

The drug candidate’s additional indication is treating sclerosing cholangitis, a chronic progressive cholestatic liver disease caused by inflammation and fibrosis of unknown intrahepatic and extrahepatic bile ducts.

According to the company, the drug candidate can significantly improve the quality of life of patients by reducing excess hepatic bile acid accumulation and inhibiting liver inflammation and fibrosis, based on multiple pharmacological effects through simultaneous stimulation of GLP-1 receptor, glucagon receptor, and GIP receptor.

“As of now, nine cases of innovative new drug candidates being developed by Hanmi have been designated as an orphan drug by either the FDA or its European counterpart, EMA,” Hanmi Pharmaceutical CEO Kwon Se-chang said. “We will do our best to accelerate commercialization for these candidates based on continuous research and development for patients suffering from rare diseases.”

FDA's ODD is a system that helps smooth 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.