Danish biotechnology company Zealand Pharma has started treating patients in a Phase III clinical trial being carried out to investigate dasiglucagon for the treatment of congenital hyperinsulinism (CHI) in children.
Dasiglucagon is a glucagon analog developed by Zealand that is said to possess a unique stability profile in a ready-to-use aqueous solution.
CHI is a rare paediatric disease caused by a genetic defect in the insulin producing cells, leading to high insulin levels and persistent low blood sugar.
The two-arm, open-label Phase III trial will assess the potential of using long-term dasiglucagon infusion to prevent hypoglycaemia in up to 32 patients aged between three months and 12 years at centres across the US, Europe, and Israel.
Ddasiglucagon plus current standard of care will be compared to standard of care alone. The primary endpoint of the trial is the number of hypoglycaemic events.
Zealand Pharma interim CEO and chief medical and development officer Adam Steensberg said: “There is a critical need for new treatments for this vulnerable paediatric patient population.
“We hope to demonstrate that dasiglucagon is effective in the prevention of persistent and dangerously low blood sugar levels in these children, which they and their families must live with every day.”
The company is planning to conduct a second Phase III trial over the coming months to evaluate the safety and efficacy of giving dasiglucagon via a pump in around 12 participants aged seven days to one year.
Children benefitting from the dasiglucagon treatment by the end of the Phase III trials will be offered the chance to continue with the therapy in a long-term, open-label extension trial.
Dasiglucagon secured orphan drug designation to treat CHI from both the US Food and Drug Administration (FDA) and European Commission in 2017.
The company is also working on dasiglucagon HypoPal rescue pen for severe hypoglycaemia and dasiglucagon dual-hormone pump therapy for diabetes management.