Dasiglucagon for congenital hyperinsulinism

Dasiglucagon is a glucagon analog that is stable in aqueous solution and is thus suitable for chronic pump use. Three clinical trials, including two pivotal studies and an ongoing long-term extension trial, evaluate the potential for chronic dasiglucagon infusion delivered subcutaneously via a pump to prevent hypoglycemia in children with congenital hyperinsulinism (CHI). The FDA and the European Commission have both granted orphan drug designation to dasiglucagon for the treatment of CHI.

The FDA granted priority review designation to dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with CHI for up to three weeks of dosing. In December 2023, the FDA issued a Complete Response Letter (CRL) due to deficiencies identified following an inspection at a third-party contract manufacturing facility. These deficiencies are not specific to dasiglucagon. The CRL did not state any concerns about the clinical data package or safety of dasiglucagon. Zealand expects to resubmit the NDA for dasiglucagon for CHI for up to three weeks of dosing in the first half of 2024 contingent on a successful reinspection of the third-party manufacturing facility.

Supporting the use of dasiglucagon in CHI beyond three weeks, the FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets, which the company also expects to submit in the first half of 2024. CGM was included as a secondary outcome measure in one of the two pivotal Phase 3 clinical trials.

In 2017, the U.S. FDA and the European Commission both granted orphan drug designation to dasiglucagon for the treatment of CHI.

Dasiglucagon is an investigational candidate, not yet approved by the U.S. Food & Drug Administration (“FDA”) for congenital hyperinsulinism, and the safety and effectiveness of dasiglucagon in this patient population has not yet been established.

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.