Zealand starts enrolment in Phase III trial of dasiglucagon for hypoglycemia
Denmark-based biotechnology firm Zealand Pharma has started patient enrolment in Phase III clinical trial of dasiglucagon to treat severe hypoglycaemia in diabetic patients.
Ideal for a ready-to-use rescue pen, dasiglucagon is a glucagon analogue with stability in liquid formulation.
Designed to be conducted in Austria, Germany, Canada and the US, the Phase III trial will assess the effect, safety, tolerability and immunogenicity of repeated single doses of 0.6mg subcutaneous dasiglucagon in 90 subjects with type 1 diabetes.
The parallel, randomised double-blind trial is set to be performed over a period of 15 weeks and will compare dasiglucagon to another glucagon analogue called GlucaGen.
Zealand Pharma president and CEO Britt Meelby Jensen said: "The initiation of Phase III clinical development of dasiglucagon, a glucagon analogue stable in liquid formulation, demonstrates Zealand's leadership and expertise in the development of peptide drugs.
"We are excited about bringing Zealand significantly closer to making the ready-to-use pen available to diabetes patients for the treatment of severe hypoglycemia."
Findings from a Phase II clinical trial demonstrated the ability of dasiglucagon to increase plasma glucose (PG) levels following insulin-induced hypoglycemia, when compared with GlucaGen.
The drug's safety profile was found to indicate two post-dosing hypoglycemia events with dasiglucagon compared to nine events in case of GlucaGen.
The firm is in the process of developing another dasiglucagon formulation for use in a dual-hormone artificial pancreas and is also being investigated for congenital hyperinsulinism treatment.