Enrollment completed in phase III trial of dasiglucagon in children with congenital hyperinsulinism.

This Phase III study is the last in the program which constitute the largest clinical development program ever conducted in CHI.

CHI is the most frequent cause of severe and persistent hypoglycemia. It starts as early as the neonatal period and profoundly affects those children and their families through infancy and teenage years. It is characterized by an excessive and uncontrolled insulin secretion triggering recurrent episodes of profound hypoglycemia which require constant surveillance and rapid and intensive interventions to prevent neurological sequelae.

The 17103 Phase III trial is a pivotal, double blind and placebo controlled randomized trial designed to investigate the potential for chronic dasiglucagon infusion delivered via a pump to prevent hypoglycemia in children with CHI. The primary objective of the trial is to reduce or eliminate the need for intensive hospital treatment, reduce the frequency of dangerous low blood glucose and need for constant feeding, and to potentially delay or eliminate the need for pancreatectomy.

The FDA and the European Commission both granted orphan drug designation to dasiglucagon for the treatment of CHI. The first Phase III trial in the program was reported in December 2020. That trial evaluated children aged 3 months to 12 years old with more than three hypoglycemic events per week despite previous near-total pancreatectomy and/or maximum medical therapy. Top line results from the second Phase III trial are expected in the second quarter of 2022 and if the trial is positive Zealand plans to file for marketing approval with the FDA based on data from both Phase III trials and an ongoing long-term extension safety trial.