Zealand's Dasiglucagon Hits the Mark in Phase III Pediatric Hypoglycemia Trial
Shares of Zealand Pharma A/S are climbing in premarket trading after the company posted another late-stage success for dasiglucagon in treating severe hypoglycemia. This time, the treatment showed its strength in treating pediatric patients with diabetes.
Zealand Pharma said it achieved primary and all key secondary endpoints in a Phase III trial with dasiglucagon for severe hypoglycemia in pediatric patients. The positive results mark the fourth-straight Phase III success for Zealand’s dasiglucagon. Zealand noted that the median time to recovery from low blood glucose in pediatric patients was 10 minutes following an injection of dasiglucagon. The Denmark-based company said the results confirm the fast recovery also seen in adult patients with diabetes. The study results support the use of same dose of dasiglucagon in adults and children, the company noted. With the latest Phase III results, as well as other late-stage trials, Zealand said it is in track to file a New Drug Application with the U.S. Food and Drug Administration in early 2020.
Dasiglucagon, a potential first-in-class soluble glucagon analog. Is being developed for use with the HypoPal rescue pen for fast treatment of diabetes patients having a severe hypoglycemic event. Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy. The Phase III pediatric trial compared the glycemic response to dasiglucagon with that of placebo and that of Novo Nordisk’s GlucaGen. Dasiglucagon showed itself to be superior to placebo in the time of response to blood glucose recovery. GlucaGen had a similar response time to Zealand’s product.
Adam Steensberg, Zealand Pharma’s chief medical and chief development officer, said he was thrilled with another positive Phase III trial for dasiglucagon.
“This study in children with diabetes confirms the potential for fast and effective rescue from severe hypoglycemia also seen in our Phase III trials in adults, and keeps us on track for submitting the new drug application to the U.S. FDA in early 2020,” Steensberg said in a statement.
Emmanuel Dulac, president and chief executive officer of Zealand, echoed Steensberg’s enthusiasm to the trial results. Dulac said the data showed that the dasiglucagon HypoPal rescue pen has the potential to significantly improve management of severe hypoglycemia in diabetes. Dulac said the 10-minute response time is critical to any rescue situation for diabetes patients.
“Speed of recovery is critical in any rescue situation, and our vision is for every patient at risk of severe hypoglycemia to have the HypoPal rescue pen readily available,” Dulac said.
Zealand said no safety concerns were raised during the trial. Nausea and vomiting were on par with the frequency reported in a previous Phase III trial, the company said.
In a previous Phase III trial reported in May, adults also experienced a 10 minute response time compared to about 35 minutes for placebo. Zealand noted that the same 10 minute time shown for its product with HypoPal was identical to the administration of dasiglucagon with a pre-filled syringe shown in a previous Phase III trial.