Dasiglucagon for congenital hyperinsulinism
Congenital hyperinsulinism (CHI) is a rare disease affecting mainly newborns and toddlers. It is caused by a defect in pancreatic cells, resulting in insulin overproduction. This leads to persistently and often severely low blood sugar levels (hypoglycemia). CHI develops in one out of 50,000 (or fewer) children. This corresponds to 180-300 children diagnosed in the U.S. and Europe every year.
The most severely affected children need to have their pancreas surgically removed within a few months of birth in order to prevent hypoglycemia. This invariably results in the development of type 1 diabetes.
Current treatment options are insufficient: Fewer than one-third of newborns and two-thirds of older children respond to approved medical therapy.
In 2017, the U.S. FDA and the European Commission both granted orphan drug designation to dasiglucagon for the treatment of CHI.
Zealand is developing dasiglucagon as a potential treatment option for CHI, a rare disease which affects mainly newborns and toddlers with devastating consequences including brain damage and often requires surgical intervention, pancreatectomy, to manage the condition. The FDA’s approval of our IND application allows us to proceed into Phase 3 development of dasiglucagon and we will conduct two Phase 3 trials. The first trial is ongoing, and the second trial is expected to initiate mid 2019.