Dasiglucagon cuts IV glucose requirement in Pediatric Patients with Congenital Hyperinsulinism: Phase 3 Trial
reducing the requirement for IV glucose
Zealand Pharma has announced positive topline results from a second phase 3 trial evaluating dasiglucagon in pediatric patients with congenital hyperinsulinism. The Phase 3 program for dasiglucagon constitutes the largest clinical development program ever conducted in CHI. According to the results of the trial, Dasiglucagon cuts IV glucose requirement in Pediatric Patients with Congenital Hyperinsulinism.
In this global trial of 12 children with CHI (ranging in age from 7 days to 12 months) dasiglucagon met the primary endpoint of the trial by demonstrating a statistically significant difference between treatment arms. Baseline intravenous glucose infusion rate (IV GIR) was 15.7 mg/kg/min.
Dasiglucagon treatment resulted in a significant reduction in the mean IV GIR versus placebo as measured during the last 12 hours of each treatment period (4.3 mg/kg/min for dasiglucagon and 9.4 mg/kg/min for placebo with a treatment difference of 5.2 mg/kg/min; p=0.0037). Dasiglucagon was assessed as well tolerated in the trial with an overall safety profile consistent with that reported in the previous Phase 3 trial of older children with CHI (ages 3 months to 12 years).
In total, 42 of 44 participants enrolled across the dasiglucagon CHI Phase 3 clinical programs continued into the ongoing safety extension trial.
Based on the trial's results, Zealand Pharma will engage with the U.S. Food and Drug Administration to discuss the submission of an NDA for marketing approval. Dasiglucagon has the potential to become the first medicine developed specifically for this debilitating, ultra-rare disease in over three decades.
"We are extremely pleased with the top-line results from our second Phase 3 study of dasiglucagon for the treatment of infants with CHI. CHI is a serious ultra-rare condition with a significant unmet medical need which places a tremendous burden on both patients and families," said Adam Steensberg, President and Chief Executive Officer, Zealand Pharma.
"We believe the outcome of this trial supports the potential of dasiglucagon as a novel treatment for those living with CHI. We look forward to engaging with the U.S. FDA and moving forward with our New Drug Application."
