Positive Phase III Diabetes Data with Lixisenatide Announced by Zealand Pharma's Partner sanofi-aventis
Zealand Pharma A/S announced that sanofi-aventis, its partner, has announced the positive results of the first, placebo-controlled study of the GetGoal Phase III clinical trial program with Lixisenatide, a novel, once daily GLP-1 agonist, for the treatment of Type-2 diabetes (T2DM) licensed from Zealand Pharma.
The key highlights of the announcement are:
- Phase III study endpoints with Lixisenatide in diabetes successfully met in first reported study
- Improved glycemic control in T2DM patients dosed once daily as monotherapy
- Lixisenatide was generally well tolerated with no significant adverse events
- Complete study findings submitted for presentation at EASD in September 2010
- Phase III program with the combination of Lixisenatide/Lantus® expected to commence in 2010 - Lantus® is the number-one sold insulin in the world in both sales and units (source: IMS, 2009 sales)
Commenting on the announcement David Solomon, Chief Executive Officer and President of Zealand Pharma, said: "We are delighted to note today's announcement from our strong partner, sanofi-aventis, regarding the first successful Phase III results from the GetGoal study for Lixisenatide. These results represent a significant achievement for Zealand Pharma, and for patients with T2DM. We look forward to the ongoing clinical development of Lixisenatide by sanofi-aventis and are extremely excited about the future initiation of new Phase III studies of Lixisenatide in combination with Lantus® which are expected to commence later this year."
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