LAPSTriple Agonist (HM15211), which Hanmi Pharm is developing as a NASH (Non-alcoholic fatty hepatitis) treatment, has been designated as an orphan drug by the FDA based on another indication.
"The FDA has designated LAPSTriple Agonist (HM15211) as a rare drug to treat primary sclerosing cholangitis (PSC)," Hanmi Pharm said on March 5.
PSC is a rare disease with a very few patients due to chronic progressive bile identity liver disease.
Based on the multiple pharmacological effects of simultaneous stimulation of GLP-1 receptors, glucagon receptors and GIP receptors, the LAPSTriple Agonist is expected to reduce the accumulation of excessive liver bile acid and curb liver inflammation and fibrosis to dramatically improve patients' quality of life.
The FDA Designation of Orphan Drug is a system that supports the development and permission of treatments for rare and incurable diseases or life-threatening diseases. Various benefits will be granted, including tax breaks and exemption of the cost of applying for permits.
"A total of nine new drug candidates have been designated as rare by FDA and EMA," said Kwon Se-chang, CEO of Hanmi Pharm. "We will do our best to commercialize the drug based on continuous research and development for patients suffering from rare diseases."
