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news.Zealand Pharma announced that its dasiglucagon has met primary and all major secondary endpoints in paediatric phase 3 trial of severe hypoglycaemia.
Image: Dasiglucagon is being developed in the ready-to-use HypoPal rescue pen to treat severe hypoglycemia in diabetes patients. Photo: courtesy of Zealand Pharma A/S.
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Invented and developed by Zealand Pharma, dasiglucagon is a potential first-in-class soluble glucagon analogue with a unique stability profile in a ready-to-use aqueous solution.
Dasiglucagon is being developed in the ready-to-use HypoPal rescue pen for the treatment of severe hypoglycemia in people with diabetes.
Dasiglucagon is also under development for two additional indications, including treatment of type 1 diabetes with a next-generation artificial pancreas and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI).
Zealand Pharma executive vice president and chief medical and development officer Adam Steensberg said: “I am thrilled with yet another positive Phase 3 trial outcome for our dasiglucagon HypoPal rescue pen programme.”
The phase 3 study compared the glycemic response examined after induction of hypoglycemia and administration of dasiglucagon (0.6 mg) with that of placebo and that of GlucaGen (1mg), a currently marketed glucagon in powder form for reconstitution prior to injection.
The time to plasma glucose recovery is the primary endpoint of the trial, which recruited 42 paediatric subjects. They are divided into age groups between 6-11 and 12-17 years.
Zealand placed 21 subjects in the dasiglucagon arm, 11 in the placebo arm, and 10 in the GlucaGen arm.
The primary result showed that the median time to blood glucose recovery was 10 minutes for dasiglucagon, which was superior to placebo. GlucaGen’s The median time to recovery was 10 minutes.
The earlier immunogenicity and pivotal phase 3 studies established the safety profile of dasiglucagon and fast onset of action when administered through the HypoPal rescue pen and the pre-filled syringe in adult patients with type 1 diabetes.
Zealand Pharma president and CEO Emmanuel Dulac said: “I believe that the dasiglucagon HypoPal rescue pen and its innovative features have the potential to significantly improve management of severe hypoglycemia in diabetes.”
In July 2017, Zealand Pharma started a multinational Phase 3 clinical trial of dasiglucagon in four countries (Austria, Germany, Canada and the US).
