Date: 2016-08-11
Type of
information: Results
phase: 2
Announcement: results
Company: Zealand Pharma (Denmark)
Product: dasiglucagon (ZP4207)
Action
mechanism: glucagon analog. Dasiglucagon (ZP4207) is a glucagon peptide analog, invented and fully owned by Zealand and observed to have a favorable physical and chemical stability in liquid solution. In June 2016, dasiglucagon was proposed as an International Nonproprietary Name (pINN) for this product candidate.
Disease: severe hypoglycemia in insulin dependent diabetic patients
Therapeutic
area: Metabolic diseases
Country: Germany
Trial
details: The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as compared to marketed glucagon. (NCT02660008)
Latest
news:
- • On August 11, 2016, Zealand Pharma announced supportive results from a Phase II trial with a single-dose version of dasiglucagon as rescue treatment of severe hypoglycemia in insulin dependent diabetic patients. The primary objective of the trial was to characterize the pharmacological profile of an optimized formulation of dasiglucagon and compare it to an approved glucagon rescue product. Results from the trial showed that all subjects treated with one of the three highest doses of dasiglucagon or with the approved glucagon product achieved a blood glucose concentration of >70 mg/dL within 30 minutes of dosing. In the same dose groups, time to clinically relevant plasma glucose increases of >20 mg/dL was shown to be similar for dasiglucagon and approved glucagon with a median time of 9-10 minutes. In the trial, dasiglucagon was observed to be well tolerated and have a similar safety profile compared to approved glucagon. The full Phase II results will be published at a later date.
- • On February 4, 2016, Zealand announced that the first patients have successfully been dosed in a Phase 2 trial with ZP4207 for the treatment and control of hypoglycemia associated with diabetes. The Phase 2 trial is a single-center, randomized, double-blind trial, which will enroll 56 patients with Type 1 diabetes. The primary trial objective is to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 to be able to fully compare its effect to that of a marketed native glucagon product. Patients in the trial will be randomized to one of four groups and four different single doses of ZP4207 administered subcutaneously after an insulin-induced hypoglycemia event. In the lowest dose group, a parallel design is applied, and in dosing groups 2-4, patients will be dosed with both ZP4207 and a marketed glucagon in a crossover design.
- In Phase 1 and 1b trials, ZP4207 has shown to be safe and well-tolerated with the ability to provide a clinically relevant blood glucose response after both single and repeat daily dosing in healthy volunteers. In addition, single-dosing of ZP4207 demonstrated effects in raising blood glucose levels in Type 1 diabetes patients after an insulin-induced hypoglycemia event. Zealand has two parallel clinical development programs ongoing for ZP4207: 1) For single-dose use in an auto-injector rescue-pen to treat severe hypoglycemia in diabetes patients on insulin treatment and
2) For multiple dose use in a dual-hormone pump, referred to as an artificial pancreas, for better glucose control in diabetes patients. Zealand expects to advance into next development phase with the multiple dose version of ZP4207 in H2 2016.
Is
general: Yes
