Lixisenatide

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    8. juni 2010:Pressemeddelelse nr. 5, 2010: Zealand Pharma Announces An Extension of The Lixisenatide...

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Lixisenatide

Lixisenatide (ZP10, AVE0010) is a glucagon-like peptide 1 (GLP-1) receptor agonist that incorporates Zealand Pharma’s SIP®-technology and is targeted to treat Type 2 diabetes. 

Endogenous GLP-1 is released from the small intestine in response to food intake and stimulates insulin liberation from the pancreas when blood sugar levels are elevated. In addition, GLP-1 suppresses the production of glucagon (a hormone that stimulates release of stored sugar from the liver into the bloodstream) which also contributes to the normalization of blood glucose.  Furthermore, GLP-1 delays gastric emptying and reduces appetite which are considered important effects for the lowering of body weight that has been observed consistently with this new class of drugs.  Importantly, GLP-1 only stimulates the liberation of insulin when blood glucose levels are elevated, while it is devoid of activity when blood glucose is normal or low.  This mechanism explains the low risk of hypoglycemia (low blood glucose levels) during treatment with GLP-1 agonists. 

GLP-1 receptor agonists like Lixisenatide normalize elevated blood sugar by enhancing insulin secretion until blood sugar levels approach normal concentration.  This mode of action combines high anti-diabetic efficacy with low risk of hypoglycemia (insulin shock).

In June 2003, ZP10 was out-licensed to sanofi-aventis on a global basis. Sanofi-aventis is responsible for all further clinical development. In May 2008, sanofi-aventis started a placebo-controlled Phase III clinical trial program (GetGoal).  Sanofi-aventis announced the positive results of the first of these studies in April 2010.

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

In October 2009, sanofi-aventis initiated a Phase I clinical study with the combination of Lixisenatide/Lantus®  (Lantus® is the number-one sold insulin in the world in both sales and units). Positive results for this study were announced March 2010. A Phase III program with the combination of Lixisenatide/Lantus® is expected to commence in 2010

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