Positive Phase III Diabetes Data with Lixisenatide Announced by Zealand Pharma's Partner sanofi-aventis
Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to note today 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 today's 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."
The announcement issued by sanofi-aventis is shown below:
Once Daily Lixisenatide (AVE 0010) Given as Monotherapy Successfully Meets Phase III Study Endpoints in Diabetes
- Lixisenatide significantly reduced HbA1c vs placebo with more patients achieving HbA1c < 7%
- Significant effect on postprandial glucose
Paris, France - April 15, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the results of the first, placebo-controlled study of the GetGoal Phase III clinical trial program showed lixisenatide (AVE0010), a once-daily GLP-1 agonist, significantly reduced HbA1c vs. placebo with more patients achieving HbA1c < 7% and improved glycemic control in adult patients with type 2 diabetes.
The complete study findings have been submitted for presentation at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD), in Stockholm, Sweden, in September 2010.
"Developing new diabetes treatments, like lixisenatide, and helping patients achieve diabetes control is paramount to tackling the growing diabetes epidemic," said Dr. Marc Cluzel, Executive Vice-President, R&D, sanofi- aventis. "We are pleased with the top-line results from our first Phase III study of this novel, once-daily GLP-1 agonist and are looking forward to sharing the full results later in the year."
The 12-week study involved 361 patients with type 2 diabetes not currently receiving glucose-lowering therapy and with HbA1c between 7 and 10%. Patients were randomized to one of four once-daily treatment regimens: lixisenatide two-step titration (10 ug QD for 1 week, 15 ug QD for 1 week then 20 ug QD; n=120), lixisenatide one-step titration (10 ug QD for 2 weeks then 20 ug QD; n=119), placebo two-step titration (n=61), or placebo one-step titration (n=61).
Baseline characteristics were similar among groups in terms of mean age (53.7 +/- 10.5 years), diabetes duration (2.5 +/- 3.4 years) and HbA1c (8.04 +/- 0.9%). HbA1c was significantly reduced in both lixisenatide titration groups versus placebo, and significantly more patients in the lixisenatide groups achieved HbA1c < 7% (46.5 to 52.2% versus 26.8%). as compared to placebo. Lixisenatide also significantly improved fasting plasma glucose and two-hour post-prandial glucose with a pronounced decrease in 2-hour post-prandial glucose excursion.
Lixisenatide was generally well tolerated. The most common adverse event was, as expected with this class of drugs, nausea occurring in 20 to 24% of lixisenatide-treated patients and 4% of placebo patients. The incidence of symptomatic hypoglycemia was low (1.7%) and similar in the lixisenatide and placebo groups.
About Lixisenatide (AVE 0010)
Lixisenatide, a GLP-1, Glucagon-like peptide-1 agonist, is under development for the treatment of patients with type 2 diabetes mellitus. In the Phase IIb study, once-a-day dosing with lixisenatide was shown to be effective in lowering blood sugar with a good tolerability.
The Phase III GetGoal clinical trial program for lixisenatide started in May 2008. It is designed as multicentre, randomized placebo or active- controlled studies and has enrolled more than 4500 patients. The enrollment of the eight other studies of the GetGoal Phase III program assessing efficacy and safety of lixisenatide in adult patients with type 2 diabetes mellitus treated with various oral antidiabetic agents or insulin was completed at the end of 2009. A Phase III program with the combination of lixisenatide / Lantus® (insulin glar! gine [rDNA] injection) is expected to start later this year.
Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, about 40 percent of those diagnosed are not achieving the blood sugar control target of HbA1c < 7 percent recommended by the ADA.The HbA1c test measures average blood glucose levels over the past two- to three-month period.
About sanofi-aventis Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Zealand Pharma A/S
Zealand Pharma A/S is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs. Zealand is one of the leaders within the peptide area, a growing market with significant drug development activities including treatment of diabetes, obesity, gastro- intestinal, metabolic and cardiovascular diseases. All of Zealand's products target diseases and symptoms of significant unmet clinical need and commercial potential.
Since 1999, Zealand's scientists have built a pipeline that includes five compounds in clinical development, four of which have been out licensed, three of these to major pharmaceutical companies (sanofi-aventis, Wyeth (now Pfizer) and Helsinn Healthcare). All Zealand's compounds emerge from Zealand's own drug discovery.
* Lixisenatide (AVE0010/ZP10), a pharmaceutical agent for the treatment of T2DM, has been out-licensed to sanofi-aventis, which is the world's third largest pharmaceutical corporation with a strong Diabetes franchise.
* GAP-134/ZP1609; a gap junction modifier that prevents both ventricular and atrial arrhythmias in animal models. With its oral formulation, the molecule represents a novel paradigm for the potential chronic prevention of atrial arrhythmias. US based pharmaceutical giant Wyeth Pharmaceutical (now Pfizer) has finalized a Phase I trial in the US.
* ZP1846 is an innovative treatment for prevention of chemotherapy- induced diarrhea, which may prevent discontinuation and dose modification during cancer chemotherapy. A Phase I clinical trial has been conducted in the US. The compound has been partnered with Helsinn Healthcare SA.
* ZP1848 is a novel paradigm for the treatment of Inflammatory Bowel Diseases (e.g. Crohn's Disease). The compound has completed Phase I clinical development in the US.
* AP214/ZP1480 for Post-surgical Organ Failure, partnered with Action Pharma, currently in clinical Phase II development.
In addition, Zealand has a rich and broad portfolio of pre-clinical projects targeting a variety of disease areas, including osteoporosis and obesity- related Diabetes.
Zealand Pharma A/S is based in Copenhagen. The Company's investors include LD Pensions, Dansk Erhvervsinvestering and Sunstone Capital as well as the leading international biotech investors CDC Innovation and Allianz Private Equity (both in Paris) and LSP (Amsterdam).