Phase III trial of ZP 4207 meets primary endpoint in severe hypoglycemia in diabetes.- Zealand Pharma.

Zealand Pharma announced it has achieved primary and key secondary endpoints in the pivotal Phase III trial with ZP 4207 (dasiglucagon) for severe hypoglycemia in diabetes. The pivotal Phase III trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia.

The trial compares the glycemic response observed after administration of dasiglucagon with that of placebo and that of currently marketed glucagon, in powder form for reconstitution prior to injection. The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of more than or equal to 20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. 168 subjects were included in the trial: 82 to the dasiglucagon arm, 43 to the placebo arm, and 43 to the GlucaGen arm. The primary result demonstrates that the median time to blood glucose recovery was 10 min for dasiglucagon, which was superior to placebo (median: 40 min; p<0.001). the median time to recovery for glucagen was 12 min. 99% of subjects were recovered from the insulin-induced hypoglycemia within 15 min following dosing with dasiglucagon, versus 2% with placebo and 95% with glucagen. overall, no safety concerns were raised for dasiglucagon within the trial. nausea and vomiting were reported with similar numbers for dasiglucagon and glucagen (nausea: 55% and 53%, vomiting: 23% and 19%, respectively).>

Comment: Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal rescue pen for easy, fast and effective treatment of severe hypoglycemia. This is the second Phase III trial with positive results for dasiglucagon. The previous Phase III trial confirmed dasiglucagon's safety profile. Zealand will soon initiate a Phase III trial in pediatric diabetes patients, which is expected to complete in mid-2019.