Zealand Pharma reports positive results for its type 1 diabetes drug

Zealand Pharma has reported positive results from a Phase 2a trial following administration of the multiple-dose version of dasiglucagon in adult patients with type 1 diabetes.

Zealand said that the Phase 2a trial was initiated in December 2016 to assess the efficacy, safety and tolerability of different doses of the concentrated formulation of dasiglucagon for pump use. The primary objective was to characterize the pharmacokinetic and pharmacodynamic properties of dasiglucagon 4 mg/ml formulated with preservatives.

The trial was a double-blind, randomized, four-period, sequential complete crossover trial in patients with type 1 diabetes. Four different doses of dasiglucagon were tested under normal blood glucose level (euglycemia) and low blood glucose level (hypoglycemia) conditions and with reference to responses observed with freshly reconstituted glucagon.

A clear dose-response with increases in blood glucose levels was observed across the broad dose range tested, allowing for titration of dasiglucagon to counteract present or incumbent hypoglycemia. All dasiglucagon doses provided clinically relevant mean increases in blood glucose (mean plasma glucose increases of 20 mg/dl or more) under both euglycemic and hypoglycemic conditions.

Adam Steensberg, Chief Development and Medical Officer of Zealand, comments: “We are very pleased with the Phase 2a results. Dasiglucagon in a dual-hormone artificial pancreas system holds the potential for patients to live more spontaneously with tight glucose control, without the constant fear of hypoglycemia and worry about their disease. Such systems can potentially transform type 1 diabetes management. We look forward to the results of the next Phase 2a study with dasiglucagon in the Beta Bionics iLet system at the end of June and to progressing this opportunity further into development for the future benefit of patients.”

Zealand said that it expects to report top-line results from a second Phase 2a trial, which is conducted under this partnership, by the end of June 2017, after which we will decide on the next clinical development steps.