Sanofi and partner Zealand Pharma have presented more promising late-stage data showing that their investigational diabetes drug lixisenatide reduced blood sugar levels and delivered a significant decrease in weight loss.
Top-line results from the 495-patient Phase III GetGoal-L study showed that lixisenatide, now officially known as Lyxumia, as an add-on therapy to basal insulin (with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c levels without significantly increasing the risk of hypoglycaemia versus placebo for patients with type 2 diabetes. In addition, patients treated with lixisenatide had significantly improved postprandial plasma glucose after a test meal and also reported a significant reduction in body weight.
David Solomon, Zealand's chief executive, said the efficacy and safety data "continues to be strong and supportive" further demonstrating "the near-term value potential of Lyxumia as an attractive new drug", either as monotherapy or in combination with Sanofi's blockbuster Lantus (basal insulin).
GetGoal-L is the fifth of nine studies to report positive data for lixisenatide. The drug, a once-daily GLP-1 receptor agonist, is being viewed by many observers as a blockbuster and analysts at Jefferies issued a research note saying that "importantly, in our view, this trial did demonstrate significant weight loss".
They concluded by saying that "Sanofi should ensure blockbuster commercial success, largely driven by a Lantus combination".