Candidate for congenital hyperinsulinemia and short bowel syndrome treatment
Hanmi Pharm announced on the 21st that its new drug candidates for rare diseases’Glucagon Analog’ (HM15136) and’GLP-2 Analog’ (HM15912) were approved by the US Food and Drug Administration (FDA) for a phase 2 clinical trial plan.
Hanmi Pharm is developing an analogue of glucagon as a new drug to treat congenital hyperinsulinemia.
Hanmi Pharmaceutical’s platform technology’Labs Coverage’, which extends the duration of drug efficacy of biopharmaceuticals, is applied and is being developed as a once-a-week dosage form.
Congenital hyperinsulinemia is a rare disease that occurs in about 1 in 25,000 to 50,000 people.
Until now, there are no approved treatments for the disease, so patients are either using drugs (off-label) other than licensed or relying on surgical operations.
For this reason, the US FDA and the European Medicines Agency (EMA) designated the glucagon analog as an orphan drug for congenital hyperinsulinemia in 2018.
In 2020, EMA was additionally designated as an orphan drug for insulin autoimmune syndrome, and the FDA designated it as a pediatric rare drug (RPD).
The GLP-2 analog is also being developed as a new drug for treating short bowel syndrome, which can continue to be effective even if administered once a month using Labscover technology.
Short bowel syndrome is a rare disease that causes sudden malnutrition due to malabsorption due to the loss of more than 60% of the entire small intestine through congenital or postnatal surgical resection.
It occurs in 5 or less per 100,000 (24 per 100,000 newborns).
The GLP-2 analog maximizes the effect of promoting the growth of villous cells, increasing the efficiency of nutrient absorption in patients.
The U.S. FDA and European EMA designated the GLP-2 analog as an orphan drug for treating short bowel syndrome in 2019, and as a pediatric rare drug (RPD) in 2020.
/yunhap news
Ⓒ Hankyung.com prohibits unauthorized reproduction and redistribution