Zealand Pharma presents clinical and non-clinical evidence for dasiglucagon rescue therapy at the 80th Scientific Sessions of the American Diabetes Association.

Zealand Pharma A/S presented elaborated results from two Phase III clinical studies with dasiglucagon as treatment for severe hypoglycemia as well as one preclinical PK/PD study investigating aqueous versus DMSO formulations of glucagon and the pharmacodynamics of dasiglucagon in aqueous solution at the 80th Scientific Sessions of the American Diabetes Association (ADA) held as a virtual meeting June 12-16, 2020.

Dasiglucagon, a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma, has the potential to offer millions of people living with diabetes fast and effective treatment for severe hypoglycemia. It has been developed in the ready-to-use HypoPal rescue pen for easy, fast and effective treatment.

In an oral presentation, Professor Tadej Battelino, Professor of Pediatrics, University Children’s Hospital Ljubljna presented “Dasiglucagon as a Fast and Effective Treatment for Severe Hypoglycemia in Children with Diabetes” (Abstract number: 180-OR). This Phase III, three-arm, parallel trial in 42 children in the age range of 6-17 years old with Type 1 diabetes, investigated the recovery from insulin-induced hypoglycemia with dasiglucagon versus placebo and with Glucagen as a reference. Primary and all secondary endpoints were met and demonstrated a median time to plasma glucose recovery of 10 minutes with dasiglucagon and 30 minutes for placebo (p<0.001) and 10 minutes for Glucagen. Dasiglucagon showed adverse events consistent with known class effects. No serious or severe adverse events were reported.

Dr. Timothy Bailey, President and CEO of AMCR Institute, presented a poster entitled “Dasiglucagon HypoPal Autoinjector as a Fast and Effective Treatment for Severe Hypoglycemia: Results of a Phase III Trial”. (Abstract Number: 1053-P). This Phase III parallel, two-arm study in 45 adults with Type 1 diabetes, investigated the recovery from insulin-induced hypoglycemia with dasiglucagon versus placebo. All primary and secondary endpoints were met and the median time to plasma glucose recovery was 10 minutes with dasiglucagon versus placebo 35 minutes, (p<0.0001). Dasiglucagon was generally safe and well-tolerated and these results were consistent with prior pivotal Phase 3 trials evaluating dasiglucagon administered via a pre-filled syringe.

Dr. Carola Wenander, Principal Scientist, In Vivo Pharmacology at Zealand Pharma, presented a poster entitled “PK/PD of Glucagon and the Novel Glucagon Analog, Dasiglucagon, in Aqueous or Non-Aqueous formulations following SC Administrations in Rats ” :(Abstract Number: 1091-P). This PK/PD study in male Sprague-Dawley rats characterized the pharmacokinetics of glucagon in aqueous formulation (phosphate buffered solution) and that formulated in DMSO, and compared these to the pharmacodynamics of dasiglucagon in an aqueous formulation. The pharmacodynamic results of this preclinical model demonstrated that there was comparable blood glucose increase with glucagon and dasiglucagon in aqueous formulations. Glucagon in DMSO showed a delayed increase in blood glucose.