Zealand Pharma has doesd its first patient in Phase 3 trial with dasiglucagon for the treatment of congenital hyperinsulinism, the company said Wednesday.
“With the first child dosed, this Phase 3 trial takes an important step toward establishing dasiglucagon as a potential treatment of congenital hyperinsulinism,” said Adam Steensberg, Interim CEO and Chief Medical and Development Officer at Zealand.
He pointeed out the need for new treatments for the young 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,” he said.
A second Phase 3 trial is anticipated to begin in 2019. The trial will similarly evaluate safety and efficacy of administering dasiglucagon via a pump, but in potentially 12 children (aged 7 days to 1 year).
Additionally, Zealand noted in its press release that it is also pursuing several indications where dasiglucagon’s stable profile could provide new treatment options: dasiglucagon HypoPal® rescue pen for severe hypoglycemia and dasiglucagon dual-hormone pump therapy for diabetes management.