Zealand Pharma, a Copenhagen-based biotechnology company, said that a pivotal phase 3 trial evaluating dasiglucagon in patients with severe hypoglycemia in diabetes has achieved primary and key secondary endpoints.
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.
The pivotal Phase 3 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 >/=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).
Zealand Pharma executive vice president and chief medical and development officer Adam Steensberg said: “I believe that the Phase 3 results are outstanding, and show that dasiglucagon HypoPal rescue pen could become the fastest rescue treatment for severe hypoglycemia. I am grateful to the patients and clinical investigators who participated in the trial.”
Medical University of Graz’ Thomas Pieber said: “The results of this Phase 3 trial are impressive in that all patients had clinical relevant increases in blood glucose level within 15 minutes, with a median time to recovery of only 10 minutes. The rapid onset of action suggests that dasiglucagon could become a very attractive treatment option for diabetes patients having a severe hypoglycemic event.”
This is the second Phase 3 trial with positive results for dasiglucagon. The previous Phase 3 trial confirmed dasiglucagon’s safety profile. Zealand will soon initiate a Phase 3 trial in pediatric diabetes patients, which is expected to complete in mid-2019.
Zealand Pharma president and CEO Britt Meelby said: “The compelling Phase 3 results bring the dasiglucagon HypoPal rescue pen a significant step closer to a better treatment for people living with diabetes, addressing one of their biggest fears.
“I am thrilled about this achievement, which represents an important milestone for Zealand in executing our strategy of bringing fully-owned products through registration.”
Source: Company Press Release.