Phase III trial of ZP 4207 (dasiglucagon) for treatment of severe hypoglycemia in type 1 diabetes meets primary endpoint.- Zealand Pharma.

Zealand Pharma announced that the primary and key secondary objectives of the first multinational Phase III clinical trial of ZP 4207 (dasiglucagon) for treatment of severe hypoglycemia in type 1 diabetes have been met. No treatment-induced or treatment-boosted anti-drug antibodies were detected in the trial. Additional results from the trial are expected in Q2 2018, and the full results will be published at an appropriate scientific conference. In addition to this trial, a pivotal Phase III efficacy trial was initiated late 2017, and patient recruitment is progressing as planned, with results expected H2 2018.

The aim of this first Phase III trial was to evaluate the immunogenicity of repeated single doses of dasiglucagon (0.6 mg) following subcutaneous administration in 90 patients with type 1 diabetes. The trial also evaluated safety and tolerability. Dasiglucagon was compared to native glucagon powder that requires immediate reconstitution in an aqueous buffer before injection with a syringe. The primary and key secondary objectives in the trial were to evaluate the risk of treatment-induced and treatment-boosted anti-drug antibodies following three repeat doses of dasiglucagon or GlucaGen. The blinded data-review of the trial demonstrates that dasiglucagon did not induce or boost anti-drug antibodies.