The trial showed that the company’s auto-injector administered treatment delivered the same results as a previous trial using a pre-filled syringe.
Shares of Zealand Pharma A/S are up more than 2 percent in premarket trading after the company announced that its Phase III treatment for severe hypoglycemia hit the mark.
Denmark-based Zealand said dasiglucagon hit all primary and secondary endpoints in the late-stage trial assessing the safety and efficacy of the glucagon analog for severe hypoglycemia in diabetes patients. Zealand noted that dasiglucagon is a potential first-in-class therapy that is in development as a ready-to-use medicine in the HypoPal auto-injector rescue pen, a product the company hopes to market soon.
The late-stage trial confirmed that a single dose of dasiglucagon administered through the HypoPal injector rapidly increased blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. Zealand said the trial compared the glycemic response for both dasiglucagon and placebo. Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy.
According to the trial results, the median time to blood glucose recovery was 10 minutes for dasiglucagon. For placebo, the median time was about 35 minutes, the company said. 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. The dasiglucagon pharmacokinetic profiles were consistent between the two trials, the company added.
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.
Zealand Chief Medical and Development Officer Adam Steensberg said he was encouraged by the results of the late-stage trial. He said the results with the HypoPal “underscore the fast and effective profile of dasiglucagon” that was noted in the Phase III trial using the pre-filled syringe.
The latest Phase III trial is the third successful late-stage trial for dasiglucagon. Zealand is conducting another trial in pediatric diabetes. Results are expected in September. That Phase III trial will complete the company’s New Drug Application to the U.S. Food and Drug Administration in early 2020, Zealand said this morning.
“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,” Emmanuel Dulac, president and chief executive officer of Zealand said in a statement. “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.”
