Zealand Pharma A/S
Zealand presents first data on novel liquid glucagon peptide agonist, showing potential to treat and/or prevent severe hypoglycemia associated with diabetes
Copenhagen, 2013-06-22 17:00 CEST (GLOBE NEWSWIRE) --
─ ZP-GA-1, an example of Zealand’s unique peptide drug design capabilities, demonstrates superior physico-chemical properties over native glucagon, while retaining similar efficacy
─ Preclinical data presented at the ADA’s 73rd Scientific Sessions suggest the use of ZP-GA-1 in the form of a ready-to-use rescue kit and/or in an artificial pancreas
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) announces 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.
The data will be presented by Zealand scientists in a poster titled
“A novel glucagon analogue, ZP-GA-1, displays increased chemical and physical stability in liquid formulation”
in a poster session on Sunday, 23 June from 12:00 – 14:00 CDT at the American Diabetes Association’s (ADA) 73rd Scientific Sessions taking place on 21-25 June 2013 in Chicago, US. The poster is available also as an ePoster on the ADA website and on Zealand’s website: www.zealandpharma.com.
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.
In conclusion, ZP-GA-1 demonstrates superior physico-chemical properties over native glucagon along with a comparable pharmaco-dynamic profile. 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.
Commenting on the findings, Zealand’s Chief Executive Officer David Solomon said:
“ZP-GA-1 is a powerful example of Zealand’s unique capabilities in peptide drug innovation and design. Being able to present a glucagon analogue suited for liquid formulation fits well with our strategy of using our competences for the benefit of diabetic patients and their caregivers.
”Hypoglycemia is a significant cause of morbidity and mortality among diabetes patients and a key limiting factor in the successful metabolic control of the disease. The risk of severe life-threatening episodes represents a real scare to patients and relatives. We are therefore encouraged by the data we present here at ADA and look forward to further investigating this compound for the potential use as a ready-to-use rescue kit – and/or as part of an artificial pancreas.”
For further information, please contact:
David Solomon, President and Chief Executive Officer – Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President, Head of Investor Relations & Corporate Communications – Tel: +45 50 60 36 89, email: email@example.com
Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) is a biotechnology company based in Copenhagen, Denmark. Zealand specializes in the discovery, optimization and development of novel peptide drugs and has a broad and mature pipeline of drug candidates identified through its own drug discovery activities. The company’s focus lies in the field of cardio-metabolic diseases, including diabetes and obesity, and its lead drug invention is lixisenatide, a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. Lixisenatide is approved and launched (March 2013) in Europe under the name of Lyxumia®, and under regulatory review in a large number of other countries globally, including in the US (NDA submission accepted in Feb 2013) and Japan (NDA filed in June 2012).
Zealand has a partnering strategy for the development and commercialization of its products and in addition to the collaboration with Sanofi in Type 2 diabetes, the company has partnerships with Boehringer Ingelheim in diabetes/obesity, Helsinn Healthcare in chemotherapy induced diarrhea and AbbVie in acute kidney injury.
For further information: www.zealandpharma.com.