Dasiglucagon lowers IV glucose needed for infants with congenital hyperinsulinism
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Dasiglucagon lowers the amount of IV glucose required by more than 50% for infants with congenital hyperinsulinism, according to top-line results from a phase 3 clinical trial.
In a second phase 3 study evaluating the use of dasiglucagon (Zegalogue, Zealand Pharma) in children with congenital hyperinsulinism, investigators examined the efficacy of the agent in reducing the need for IV glucose in infants aged 7 days to 12 months. The study cohort had a baseline IV glucose infusion rate of 15.7 mg/kg/min. During the last 12 hours following treatment, participants randomly assigned to dasiglucagon had a reduction in IV glucose infusion rate to 4.3 mg/kg/min compared with 9.4 mg/kg/min for placebo (P = .0037).
“We are extremely pleased with the top-line results from our second phase 3 study of dasiglucagon for the treatment of infants with congenital hyperinsulinism,” Adam Steensberg, president and CEO for Zealand Pharma, said in a press release. “Congenital hyperinsulinism is a serious ultra-rare condition with a significant unmet medical need, which places a tremendous burden on both patients and families. We believe the outcome of this trial supports the potential of dasiglucagon as a novel treatment for those living with congenital hyperinsulinism.”
In the first phase 3 trial, children aged 3 months to 12 years with more than three hypoglycemic events per week despite previous near-total pancreatectomy, or maximum medical therapy, were randomly assigned to dasiglucagon along with standard of care, or standard of care alone. The dasiglucagon group had a 40% to 50% reduction in hypoglycemia compared with standard of care when measured by masked continuous glucose monitoring.
The safety profile in the infant cohort was similar to what was observed in the first phase 3 trial. Of the 44 total participants enrolled in all of the phase 3 clinical programs, 42 continued into the ongoing safety extension trial.
In 2017, the FDA granted orphan drug designation to dasiglucagon for the treatment of congenital hyperinsulinism in children. Based on the trial findings, Zealand Pharma will discuss with the FDA its submission for a new drug application for marketing approval, according to the press release.
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