Sanofi-Aventis’ lixisenatide has met its primary goal in a late-stage trial by significantly lowering levels of blood glucose in patients with type II diabetes.
Top-line results from the first placebo-controlled study of the 4,500-plus patient GetGoal Phase III clinical trial program have raised hopes that lixisenatide (AVE0010), a once-daily GLP-1 agonist, may offer adults with the condition a new way to improve glycaemic control.
In the 12-week study, which involved 361 patients with levels of HbA1c between 7% and 10% who were not taking any glucose-lowering medication, patients were randomised to one of four once-daily treatment regimens: lixisenatide two-step titration, lixisenatide one-step titration, and the same with a placebo.
The results showed that HbA1c was significantly reduced in both lixisenatide groups versus placebo, and that significantly more patients receiving Sanofi’s drug achieved levels of HbA1c under 7% compared to the control group (46.5%-52.2% versus 26.8%, respectively).
In addition, lixisenatide was also shown to significantly improve fasting plasma glucose and two-hour post-prandial glucose levels, an important marker for whether blood sugar is being adequately controlled, and the drug was found to be generally well tolerated with the most common side effect reported being nausea.
Sanofi to buy Novagali?
Meanwhile, Sanofi is reportedly considering a take-over of French ophthalmology company Novagali Pharma, according to newspaper Les Echos.
Novagali Chief Executive Jerome Martinez told the paper that his firm has enough cash to last until year-end but that it would look for extra funds in the summer, and Sanofi is reportedly one of several companies in talks with the firm regarding a potential buy-out.
Sanofi shelled out around 370 million euros for eye disease specialist Fovea last year, to gain a stronger foothold in what its chief executive Chris Viehbacher called “the very promising and dynamically growing ophthalmic area”.
