- In the Phase II trial, all type 1 diabetes patients treated with dasiglucagon had a clinically relevant increase in blood glucose levels after an insulin-induced hypoglycemic event
- Zealand plans to discuss the trial results with the FDA later in 2016 to define the next development steps for dasiglucagon as a single-dose rescue treatment
COPENHAGEN, Aug. 11, 2016 (GLOBE NEWSWIRE) -- Zealand Pharma (Zealand) announces 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. Dasiglucagon, formerly referred to as 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.
Severe hypoglycemia is a potential life threatening condition and the most feared side effect associated with insulin treatment of diabetes1. At present, hypoglycemia rescue treatments are based on native glucagon and solely available as a lyophilized powder, which requires reconstitution with sterile water in a multi-step process prior to use2.
The primary objective of this Phase II 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.
Adam Steensberg, Chief Development and Medical Officer of Zealand commented:"We are pleased with the results of this Phase II trial, which we believe further support dasiglucagon's attractive profile. We have designed dasiglucagon to be stable in liquid formulation, and with the current results we believe to be one step closer to being able to offer insulin dependent diabetes patients a ready-to-use pen for convenient and fast rescue from severe hypoglycemia - or insulin shock. We see a clear need for a patient friendly rescue product and we look forward to the next step in development."
For further information, please contact:
Britt Meelby Jensen, President and Chief Executive Officer - Tel: +45 51 67 61 28, email: firstname.lastname@example.org
Hanne Leth Hillman, Senior Vice President, Investor Relations and Communications - Tel: +45 50 60 36 89, email: email@example.com
1 According to Diabetes Associations
2 Glucagon rescue kit labels
Source: Zealand Pharma A/S