Ready-to-Use Rescue Pen Successfully Treats Hypoglycemia in Diabetes Patients

Company to discuss mid-stage data with FDA

Encouraging results have been reported from a phase 2 trial of a single-dose version of dasiglucagon (Zealand Pharma) as rescue treatment for severe hypoglycemia in insulin-dependent patients with type-1 diabetes. Dasiglucagon, formerly known as ZP4207, is a glucagon peptide analogue with physical and chemical stability in liquid solution.

Severe hypoglycemia is a potentially life-threatening condition associated with insulin treatment of diabetes. Current hypoglycemia rescue treatments are based on native glucagon and are available only as a lyophilized powder, which requires reconstitution with sterile water before use.

The primary objective of the new study was to characterize the pharmacological profile of an optimized formulation of single-dose dasiglucagon and to compare it with an approved glucagon rescue product in 81 individuals with type-1 diabetes. Results from the study showed that all patients treated with one of the three highest doses of dasiglucagon or with the approved glucagon product achieved a blood glucose concentration of greater than 70 mg/dL within 30 minutes of dosing. In the same dose groups, the time to clinically relevant plasma glucose increases of greater than 20 mg/dL was shown to be similar for dasiglucagon and approved glucagon, with a median time of nine to 10 minutes. Dasiglucagon was well tolerated and had a safety profile similar to that of approved glucagon.

Armed with these new data, Zealand Pharma plans to talk to the FDA about moving dasiglucagon into phase 3 trials.

The major appeal of single-dose dasiglucagon lies in its shelf life, according to FierceBiotech. By creating a glucagon peptide analogue stable enough to be kept in a liquid solution, Zealand Pharma hopes to provide diabetic patients with a rescue pen that is ready to use. Single-dose dasiglucagon is also central to an artificial pancreas that Zealand is developing with Beta Bionics.

Sources: Zealand Pharma; August 11, 2016; and FierceBiotech; August 12, 2016.