Positive topline results were announced from a second phase 3 trial evaluating dasiglucagon in pediatric patients with congenital hyperinsulinism.

Congenital hyperinsulinism (CHI) is a rare disease that affects newborns and children resulting in persistent hypoglycemia due to the overproduction of insulin. Dasiglucagon is a glucagon analog formulated in a ready-to-use aqueous solution.

The clinical trial (ClinicalTrials.gov Identifier: NCT04172441) evaluated the efficacy and safety of dasiglucagon administered as a continuous intravenous (IV) infusion via a pump in 12 children (ranging in age from 7 days to 12 months) with persistent CHI. Baseline IV glucose infusion rate (IV GIR) was reported to be 15.7mg/kg/min.

Findings demonstrated that dasiglucagon met the primary endpoint, reducing the requirement for IV glucose by 55% when compared with placebo. A significant reduction in mean IV GIR was observed with dasiglucagon vs placebo during the last 12 hours of each treatment period (4.3mg/kg/min vs 9.4 mg/kg/min, respectively; treatment difference, 5.2mg/kg/min; P =.0037).

The safety profile of dasiglucagon was consistent with that reported in previous clinical trials. The majority of participants enrolled across the dasiglucagon CHI phase 3 clinical program (n=42/44) have continued into the long-term safety extension study (ClinicalTrials.gov Identifier: NCT03941236).

“We believe the outcome of this trial supports the potential of dasiglucagon as a novel treatment for those living with CHI,” said Adam Steensberg, President and Chief Executive Officer, Zealand Pharma. “We look forward to engaging with the US FDA and moving forward with our New Drug Application.”

Dasiglucagon is currently marketed under the brand name Zegalogue for the treatment of severe hypoglycemia in patients 6 years of age and older via subcutaneous injection.

Reference

Zealand Pharma announces positive results from phase 3 trial of dasiglucagon in pediatric patients with congenital hyperinsulinism (CHI). News release. Zealand Pharma A/S. Accessed May 19, 2022. https://www.globenewswire.com/news-release/2022/05/19/2446817/0/en/Zealand-Pharma-Announces-Positive-Results-from-Phase-3-Trial-of-Dasiglucagon-in-Pediatric-Patients-with-Congenital-Hyperinsulinism-CHI.html