Date: 2013-06-22
Type of information:
phase: preclinical data
Announcement: presentation of preclinical data at the ADA’s 73rd Scientific Sessions in Chicago:“A novel glucagon analogue, ZP-GA-1, displays increased chemical and physical stability in liquid formulation”
Company: Zealand Pharma (Denmark)
Product: ZP-GA-1 (glucagon analogue)
Action mechanism:
Disease:
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On June 22, 2013, Zealand Pharma has announced the presentation of the first data from preclinical studies of the company’s proprietary, novel glucagon analogue, ZP-GA-1, suitable for liquid formulation. The data highlight ZP-GA-1’s potential use to treat and/or prevent severe hypoglycemia in the form of a ready-to-use rescue kit and/or in an artificial pancreas.Glucagon is a peptide hormone secreted in response to low blood sugar levels. Pharmaceutically, glucagon is used for emergency treatment of severe hypoglycemia in diabetes patients treated with insulin. Glucagon however, possesses poor solubility at or near physiological pH, and is also notorious for exhibiting poor chemical and physical stability in liquid formulation. This leads to required reconstitution of the product prior to use, complicating its therapeutic application. In the studies presented by Zealand at ADA, ZP-GA-1 demonstrated good solubility and superior chemical and physical stability in liquid formulation compared to native glucagon while retaining high potency at the glucagon receptor and a comparable pharmacokinetic and pharmacodynamic profile.The physical stability of ZP-GA-1 in solution was tested over a period of 14 days at 40°C (pH 7.5, with agitation) at concentrations of 1 and 5 mg/ml, and no aggregation was detected. ZP-GA-1 also exhibits markedly improved chemical stability over native glucagon in a simple liquid formulation.The effect of ZP-GA-1 on acute glucose release was investigated and compared to native glucagon. Data from this study showed that injection of ZP-GA-1 (60 nmol/kg) induced a glucose releasing effect comparable to native glucagon (20 nmol/kg) with respect to both time to maximal effect, maximum obtainable glucose excursion and time for blood glucose levels to return to baseline.
The results of these studies suggest ZP-GA-1 as a potential candidate for the treatment and/or prevention of severe hypoglycemia in the form of a ready-to-use rescue kit or in an artificial pancreas.
