Zealand Pharma A/S, a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, announced completion of patient enrollment in the second phase 3-trial, 17103, of dasiglucagon for the treatment of Congenital hyperinsulinism (CHI) in neonates up to 12 months old. This phase 3 study is the last in the program which constitute the largest clinical development programme 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.

“We are delighted to reach this significant milestone for dasiglucagon as we work diligently to provide a much-needed treatment option for the children faced with this rare, life-threatening disease,” said Adam Steensberg, chief medical officer at Zealand Pharma. “We are extremely grateful to the patients, their caregivers and clinicians who made this trial possible and look forward to the results in the second quarter of 2022.”

The 17103 phase 3 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 3 trial in the programme 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 3 trial are expected in the second quarter of 2022 and if the trial is positive Zealand plans to file for marketing approval with the US Food and Drug Administration based on data from both phase 3 trials and an ongoing long-term extension safety trial.

CHI is a rare paediatric disease that affects mainly newborns, infants and toddlers. Due to a genetic defect in the insulin producing cells, these children have increased insulin levels, resulting in persistent and recurrent hypoglycemia throughout childhood. Current treatment options are limited, complex and may be insufficient to adequately control hypoglycemia.

Invented by Zealand Pharma, dasiglucagon is a glucagon analog that is stable in aqueous solution and is thus suitable for chronic pump use. In 2017, both the U.S. Food and Drug Administration (FDA) and the European Commission granted orphan drug designation for dasiglucagon for the treatment of CHI. In 2021 Zealand initiated a collaborating with DEKA on utilizing their continuous infusion pump for the potential treatment of CHI with dasiglucagon. Under the terms of this agreement Zealand is responsible for distribution and commercialization of the drug-device combination.

Zealand Pharma A/S is a biotechnology company focused on the discovery, development, and commercialization of peptide-based medicines.