A year after scoring FDA approval for diabetes drug, Zealand touts positive PhIII data for new indication
When Zegalogue, also known as dasiglucagon, got approved by the FDA early last year for severe hypoglycemia in diabetes patients, Zealand Pharma said that wasn’t the end of its vision for the drug. One of the other indications they planned to pursue came in pediatric patients who had congenital hyperinsulinism, a genetic disorder where the pancreas produces too much insulin that results in low blood sugar.
The results are now in from a Phase III trial, and according to the biotech, the primary endpoint has been met. The peptide specialist outfit announced Thursday that top-line results from the trial, which enrolled 12 babies with the genetic condition (ranging from 12 months all the way down to just one week old), showed a statistically significant reduction in patients requiring intravenous glucose between treatment arms versus placebo.
Investors cheered the news, sending Zealand shares $ZEAL up 18% in Thursday morning trading.
In the study, Zealand reported the mean IV GIR, a measure of how much glucose is required to keep patients’ blood sugar levels stable, in patients in the treatment arm and the placebo arm. The baseline IV GIR was 15.7 mg/kg/minute. For patients who took Zegalogue, the level was reduced to 4.3 mg/kg/min, and reduced to 9.4 mg/kg/min for the placebo group, good for a 55% reduction.
That clocked in at a p-value of p=0.0037. Additionally, 11 of the 12 patients in the study are moving into an ongoing, safety extension trial.
This study was the second Phase III that Zealand went with in CHI. The first study read out back in 2020 and looked at older children, enrolling 32 patients between the ages of 3 months and 12 years old. The pharma reported at the time that the drug plus standard of care did not significantly reduce the rate of hypoglycemia compared to standard of care alone when assessed by intermittent self-measured plasma glucose.
However, when compared to continuous glucose monitoring via an exploratory analysis, hypoglycemia was reduced by 40 to 50% with Zegalogue as compared to standard of care alone. The analysis led to 31 of those patients to enroll in the aforementioned safety extension trial.
The biotech added that now that the data are in, it’s looking at meeting with the FDA and start to pursue an NDA submission for that indication. Zealand said in a statement that it plans to have the submission done by year’s end.
“We are extremely pleased with the top-line results from our second Phase III study of dasiglucagon for the treatment of infants with CHI,” Zealand CEO Adam Steensberg said in a statement, adding, “We look forward to engaging with the US FDA and moving forward with our New Drug Application.”