Company announcement – No. 15 / 2019
Zealand Pharma achieves primary and all key secondary endpoints in confirmatory Phase 3 trial with dasiglucagon for severe hypoglycemia
Primary and all key secondary endpoints successfully achieved in the trial
Median time to recovery from low blood glucose was 10 minutes following dasiglucagon injection administered via the HypoPal® rescue pen
The dasiglucagon HypoPal® rescue pen is being developed as an easy-to-use, fast and effective rescue treatment for diabetes patients having a severe hypoglycemic event
Copenhagen, May 14, 2019 – Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces successful results in the confirmatory Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes. 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, an auto-injector for easy, fast and effective treatment of severe hypoglycemia in people with diabetes.
This Phase 3 trial confirms that a single dose of dasiglucagon administered via the HypoPal® rescue pen rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. The trial compared the glycemic response observed after dosing of dasiglucagon with that of placebo. 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. 45 subjects were included in the trial. Additional details about the trial are found at clinicaltrials.gov.
The primary result demonstrates that the median time to blood glucose recovery was 10 minutes for dasiglucagon, which was superior to placebo (median: 35 min; p<0.001) and identical to a median time to rescue of 10 minutes observed in the pivotal Phase 3 trial which used a pre-filled syringe for administration of dasiglucagon. Likewise, the dasiglucagon pharmacokinetic profiles were consistent between the two trials. Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with dasiglucagon (nausea: 62% and vomiting: 29%) and were on par with the frequency observed in the pivotal Phase 3 trial (nausea: 55% and vomiting: 23%).
Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma, commented: “I am very encouraged by the outcome of this Phase 3 trial with dasiglucagon for treatment of severe hypoglycemia in diabetes. The study used the to-be-marketed HypoPal® rescue pen, and the results underscore the fast and effective profile of dasiglucagon also seen in the pivotal Phase 3 trial utilizing a pre-filled syringe.”
This is the third consecutive Phase 3 trial with positive results for dasiglucagon. The previous immunogenicity and pivotal Phase 3 trials established dasiglucagon’s safety profile and fast onset of action when administered via a pre-filled syringe in adult patients with type 1 diabetes. The final Phase 3 trial that will complete our NDA application is in pediatric diabetes patients and is still ongoing. Recruitment for this study involving children has proved challenging and results are now expected in September 2019. Accounting for this delay in pediatric patient recruitment, submission of the new drug application (NDA) to the U.S. FDA is now expected early 2020.
“I am very impressed with the dasiglucagon HypoPal® rescue pen data and believe its innovative features have the potential to significantly transform management of severe hypoglycemia,” said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “Helping a diabetic patient through an acute crisis of severe hypoglycemia can be a highly traumatic experience. Our vision is for every patient at risk of severe hypoglycemia to have the HypoPal® rescue pen readily available.”