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

Press release – No. 09 / 2020  

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

              

• The dasiglucagon HypoPal rescue pen is under FDA review as a potential fast and effective treatment of severe hypoglycemia in diabetes
   
• In Phase 3 trials in pediatric and adult patients with diabetes, dasiglucagon has consistently demonstrated a median time to recovery from hypoglycemia of 10 minutes

Copenhagen, June 14, 2020 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company changing lives with innovative peptide-based medicines, presented elaborated results from two Phase 3 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. The New Drug Application for the treatment of severe hypoglycemia with dasiglucagon has been accepted for review by the U.S. Food and Drug Administration and given a PDUFA target action date of March 27, 2021 (Company Announcement No. 28 / 2020).

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 3, 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.