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 Pharma is developing dasiglucagon as a potential treatment option for CHI, a rare disease affecting mainly newborns and toddlers that can have devastating neurological and physical consequences and often requires surgical intervention in the form of a pancreatectomy, to manage the condition. We reported top-line results from the first of two Phase 3-trials with dasiglucagon for the treatment of patients (aged 3 months to 12 years) with CHI. A second Phase 3-trial of dasiglucagon in CHI patients aged 7 days to 3 months, is ongoing.

Collaboration with DEKA

In 2021, Zealand Pharma entered into a collaboration agreement with DEKA Research & Development Corp. to create a continuous infusion pump to be used with dasiglucagon for the potential treatment of CHI.