Copenhagen, 2012-10-02 12:13 CEST (GLOBE NEWSWIRE) --
Press Release
No. 7/2012
- Clinical study results show that the mechanism of action of lixisenatide as a once-daily GLP-1 agonist significantly delays gastric emptying, accompanied by a significant lowering of post-prandial glucose (PPG) throughout the day
- Presented also at EASD, are results from the GetGoal Duo 1 and GetGoal-L Phase III studies
Copenhagen, 2 October 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) informs that its partner Sanofi (EURONEXT: SAN and NYSE: SNY) at the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD), 1-5 October in Berlin, will present results from clinical studies, supporting the clinical rationale for lixisenatide as a once-daily GLP-1 receptor agonist to be used potentially in combination with basal insulin for improved glycemic control in Type 2 diabetes.
Lixisenatide is an investigational once-daily GLP-1 agonist for the treatment of Type 2 diabetes, discovered by Zealand Pharma and licensed to and developed by Sanofi.
In a poster under the title;
“Effects of lixisenatide once daily on gastric emptying and its relationship to postprandial glycaemia in Type 2 diabetes mellitus” [Abs 808-EASD]
Sanofi presents results from a 28-day, randomized, double-blind, placebo-controlled, parallel-group study of 20μg lixisenatide once-daily in patients with Type 2 diabetes (lixisenatide n=19; placebo n=22). In the study, treatment after a standardized breakfast with a final dose of lixisenatide (final dose reached after titrating from 5–20μg with 2.5μg increments every 4 days) plus up to two OADs contributed significantly to slowing the rate of gastric emptying, compared with placebo (p=0.0031) with a pharmacodynamic effect on blood glucose levels throughout the day. Delayed gastric emptying is associated with lower PPG levels, and for the patients treated with lixisenatide, PPG was significantly reduced at day 28 after a standardized breakfast (p<0.0001), after lunch (p=0.0004) and after dinner (p=0.0082). No such relationship was found for placebo.
Also presented at EASD (and previously at the American Diabetes Association scientific sessions 2012) were results from the GetGoal Duo 12 and GetGoal-L3 Phase III studies;
“Once-daily lixisenatide added on to consistently titrated insulin glargine plus oral agents in Type 2 diabetes: The GetGoal Duo 1 study” [Abs 807-EASD] and “Efficacy and safety of once-daily lixisenatide in Type 2 diabetes insufficiently controlled with basal insulin ± metformin: GetGoal-L study” [Abs 3-EASD]
Results from the studies demonstrate that lixisenatide in combination with basal insulin plus oral anti-diabetic agents (mostly metformin in GetGoal Duo 1, with or without metformin in GetGoal-L) significantly reduced HbA1c in patients with Type 2 diabetes who were either new to insulin therapy (as early as 12 weeks after initiation) or already treated with insulin (for an average of 3.1 years), respectively. Both GetGoal Duo 1 and GetGoal-L achieved the primary efficacy endpoint of HbA1c improvement with an associated significant reduction in PPG.
The results also showed that lixisenatide caused mild and transient nausea and vomiting, the most common adverse events, and a limited additional or comparable risk of hypoglycemia.
GetGoal Duo 1 and GetGoal-L are part of the GetGoal Phase III clinical program for lixisenatide, which includes a broad range of patients with Type 2 diabetes, including a large number of patients treated with basal insulin (706 patients in three trials) 4.
To achieve target blood glucose levels, both fasting plasma glucose (FPG) and PPG need to be addressed5. Basal insulin therapies provide effective FPG control, but due to disease progression some patients over time might no longer be at their glycemic targets and need additional treatment to further address uncontrolled HbA1c. A GLP-1 agonist that has a pronounced PPG effect in combination with basal insulin may therefore be beneficial for those patients.
In Sanofi’s press release, Pierre Chancel, Senior Vice-President, Global Diabetes at Sanofi, commented: “The positive data for Lyxumia® (lixisenatide) are of particular significance as the new Position Statement of the ADA and EASD recognizes that combining therapies may be helpful. Taken together, the results from the GetGoal Duo 1 and GetGoal-L trials, as well as lixisenatide’s significant effect on gastric emptying and PPG, support the clinical rationale for the potential use of our investigational GLP-1 receptor agonist in combination with basal insulin to improve glycemic control by addressing both PPG and FPG.”
David H. Solomon, President and CEO of Zealand Pharma, added: “We are greatly encouraged to see further results which confirm the effects of lixisenatide in delaying gastric emptying and significantly reducing post-prandial glucose (PPG). Effective lowering of PPG contributes to improved glycemic control for patients with Type 2 diabetes, including patients treated with basal insulin, and as part of the GetGoal program lixisenatide has shown to significantly reduce HbA1c in combination with basal insulin while demonstrating a good safety profile.”
Development status for lixisenatide (Lyxumia®)
In November 2011, the European Medicines Agency (EMA) acknowledged receipt of Sanofi’s Marketing Authorization Application filing for lixisenatide (Lyxumia®), and in June 2012 a New Drug Application was filed with the Pharmaceuticals and Medical Devices Evaluation Agency in Japan. Submission for regulatory approval of lixisenatide in the US is expected in December 2012.
References
- Lyxumia is the proprietary name submitted to the EMA for lixisenatide, an investigational once-daily GLP-1 agonist, invented by Zealand Pharma and licensed to and developed by Sanofi for the treatment of Type 2 diabetes. The proprietary name for lixisenatide in the United States is under consideration. Lixisenatide is not currently approved or licensed anywhere in the world.
- Rosenstock et al. Diabetes Care 2012; 35: A18 (62-OR)
- Riddle et al. Diabetes Care 2012; 35: A251 (983-P)
- http://clinicaltrials.gov/ct2/results?term=GetGoal. Date assessed: Aug 2012
- Riddle. M et al. Diabetes Care. 2011; 34: 2508-2514
# # #
For further information, please contact:
Zealand Pharma A/S
David H. Solomon, President & CEO, Tel: +45 22 20 63 00
Hanne Leth Hillman, Vice President, Director of IR & Corporate Communication,
Tel: +45 50 60 36 89, email: hlh@zealandpharma.com
About lixisenatide (Lyxumia®)
Lixisenatide (Lyxumia®) is a once-daily GLP-1 drug, invented by Zealand Pharma, and developed through a global license partnership with Sanofi both as a stand-alone product and in a combination pen with Lantus® (insulin glargine), Sanofi’s world-leading basal insulin product. The GetGoal Phase III clinical program, which completed in February 2012, provided data for lixisenatide (Lyxumia®) in adults with Type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal program started in May 2008 and enrolled more than 5,000 patients.
Phase III studies of a lixisenatide and Lantus® combination drug based on a pen device allowing for flexible Lantus dosing with a fixed lixisenatide dose are on track to start in early 2013.
About GLP-1 receptor agonists
GLP-1 (glucagon-like peptide-1) is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and to stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are members of an established class of diabetes drugs approved by regulatory authorities and marketed globally as an add-on treatment for patients with Type 2 diabetes. Their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology. Several novel GLP-1 receptor agonists are in development.
About Diabetes
Diabetes is a long-term disease that occurs either when the pancreas does not produce enough insulin (the hormone that regulates blood glucose concentrations), or when the body cannot effectively use the insulin it produces, or both. This results in raised blood glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia leads to the macrovascular and microvascular complications of diabetes. Macrovascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Microvascular complications affect the small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves (neuropathy). The incidence of Type 2 diabetes is growing at an alarming rate. Over 310 million people worldwide are living with the condition today and the number is expected to increase to more than 550 million people by 2030.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with Type 1 or Type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral anti-diabetic agents.
About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Zealand Pharma
Zealand Pharma A/S (NASDAQ OMX: ZEAL) is a biotechnology company based in Copenhagen, Denmark. Zealand Pharma 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 lead drug invention is lixisenatide (Lyxumia®), a once-daily GLP-1 agonist, which is licensed to Sanofi for the treatment of Type 2 diabetes. In November 2011, Sanofi filed for registration of lixisenatide in Europe and regulatory filing in the United States is expected in Q4 2012.
Zealand Pharma 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, Abbott in acute kidney injury and Helsinn Healthcare in chemotherapy induced diarrhea. Zealand Pharma focuses its activities in disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high.
