Pharmaceutical company Sanofi announced on Monday that a second late-stage Phase III clinical trial of its new diabetes medication LixiLan had met its primary target.
The study results of the drugs so far show that by administering the combination drugs through one injectable preparation, the average blood glucose level showed a decline in the past three months compared to the use of a single drug Lantus alone.
With results from both trials, regulatory submissions are on track for the fourth quarter in the USA and the first quarter of next year in the European Union.
Lixisenatide was in-licensed from Zealand Pharma A/S, and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.
Lixisenatide is a prandial GLP-1 receptor agonist, invented by Zealand, and marketed globally outside the United States by Sanofi as Lyxumia for the treatment of Type 2 diabetes.
Almost 400 million people worldwide have diabetes, with type 2 accounting for more than 90 percent of cases.
Zealand added that “Full results will be communicated in a future scientific forum. The revenue prospects from LixiLan are important for Zealand to help support the advance and accelerated value creation of our proprietary pipeline”.
The LixiLan-L Phase III trial reached its target goal in patients suffering from type 2 diabetes that were treated with insulin glargine with or excluding metformin.
Under the global license agreement with Sanofi, covering lixisenatide (Lyxumia) and LixiLan, Sanofi is responsible for all development and commercialization including the financing, while Zealand is eligible to receive event driven milestone payments and royalties on global sales. The study involved 736 patients with T2D whose A1C was not adequately controlled with basal insulin, either alone or in combination with 1 or 2 oral anti-diabetic agents. Lixisenatide is an investigational product in the US.