Zealand Pharma Doses First Patient in Phase 3 Trial with Dasiglucagon for Treatment of Congenital Hyperinsulinism

Zealand Pharma (NASDAQ:ZEAL) has announced the dosing of the first patient in the first Phase 3 trial to evaluate dasiglucagon as a potential treatment option for children with congenital hyperinsulinism (CHI).

As quoted in the press release:

“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.”

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. Trial details are available at clinicaltrials.gov.

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.”

Click here to read the full press release.