Denmark-based biotechnology company Zealand Pharma has reported positive outcome for its dasiglucagon in the paediatric Phase 3 trial for severe hypoglycaemia in diabetes.
Dasiglucagon is a potential soluble glucagon analogue being developed in the ready-to-use HypoPal rescue pen format.
According to the company, the auto-injector is designed to serve as a quick and effective rescue treatment for diabetic patients with severe hypoglycaemic.
Zealand Pharma president and chief executive officer Emmanuel Dulac said: “I believe that the dasiglucagon HypoPal rescue pen and its innovative features have the potential to significantly improve management of severe hypoglycaemia in diabetes.
“Dasiglucagon has repeatedly demonstrated fast recovery from hypoglycaemia, typically within ten minutes from injection. Speed of recovery is critical in any rescue situation, and our vision is for every patient at risk of severe hypoglycaemia to have the HypoPal rescue pen readily available.”
The study saw the participation of 42 paediatric subjects, who were divided into age groups of six to 11 and 12 to 17 years.
During the trial, 21 of them were placed in the dasiglucagon unit, 11 in the placebo group, and ten in the GlucaGen arm.
Zealand compared the glycaemic response observed after induction of hypoglycaemia and administration of 0.6mg dasiglucagon with placebo and 1mg of GlucaGen.
Dasiglucagon showed the median time to blood glucose recovery as ten minutes compared to 30 minutes for placebo and ten minutes for GlucaGen.
Zealand Pharma executive vice-president and chief medical and development officer Adam Steensberg said: “This study in children with diabetes confirms the potential for fast and effective rescue from severe hypoglycaemia also seen in our Phase 3 trials in adults, and keeps us on track for submitting the new drug application to the US FDA in early 2020.”