The company has announced the dosing of the first patient in their first Phase 3 trial to evaluate dasiglucagon as a potential treatment option for children with CHI.
“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. “There is a critical need for new treatments for this vulnerable pediatric 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.”
About the Phase 3 trial
In the Phase 3 trial, Zealand will evaluate the potential of long-term dasiglucagon infusion to prevent hypoglycemia in the CHI children. The two-arm, open-label trial comprises up to 32 children with CHI, aged 3 months up to 12 years, and will compare children treated with the current standard of care versus children on the same standard of care plus dasiglucagon infusion. The primary endpoint is the number of hypoglycemic events. The trial is being conducted at sites in the United States, Europe and Israel.
Dr. Indi Banerjee, the Head of the North England CHI NHS service and lead Principal Investigator in the trial said, “I am excited to witness the initiation of the first Phase 3 drug development program specific to this complex rare disease. If successful, it could have significant impact on the brain development of the affected children, and allow their families to regain control of their lives.”
A second Phase 3 trial
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).
All children deriving benefit from dasiglucagon treatment by the end of these trials will be offered continuation of treatment in a long-term, open-label extension trial.