Sanofi-Aventis and Zealand Pharma have unveiled yet more impressive late-stage data showing that their investigational diabetes drug lixisenatide reduced HbA1c and delivered a significant decrease in weight loss.
The French drugmaker presented top-line results of the GetGoal-S Phase III clinical trial which showed that lixisenatide, a once-daily GLP-1 receptor agonist used as an add-on to sulfonylureas, achieved its primary efficacy endpoint of significant HbA1c reduction, improved glycaemic control from baseline versus placebo and led to a significant decrease in body weight. The study is the largest of nine in the GetGoal Phase III clinical programme and the fourth to provide positive results; further resuts are expected throughout the year.
Pierre Chancel, head of Sanofi's recently-established global diabetes division, said the results of GetGoal-S "are another positive step for lixisenatide and reinforce the efficacy and safety profile of this new GLP-1”. He added that the demonstration of benefits in terms of improving glycaemic control and reducing body weight in this population, "without significantly increasing the risk of symptomatic hypoglycemia, confirmed that lixisenatide is a potential important new therapy in type 2 diabetes".
The data is clearly more good news for Zealand, the Danish company which is attracting much attention from the investment community. Analysts at Jefferies issued a note saying that the lixisenatide franchise has blockbuster potential as it expects worldwide sales of once-daily GLP-1s to reach $2.5 billion by 2018, "with convenient once-weekly forms potentially catapulting the market to over $4.5 billion".
They believe that a lixisenatide combination with Sanofi's top-selling product Lantus (basal insulin) "is likely to be the primary value driver for Zealand and represent a paradigm shift in type 2 diabetes treatment". With help from milestones from Sanofi, Jefferies expects the Copenhagen-headquartered firm (on which it has a 'buy' rating) to maintain "a comfortable funding position while still investing in its early-stage metabolic and gastrointestinal pipeline".
If approved, lixisenatide will compete with Novo Nordisk's Victoza (liraglutide) and Amylin/Eli Lilly's Byetta (exenatide), both GLP-1s.