Copenhagen, 31 May 2011 – Zealand Pharma A/S (NASDAQ OMX: ZEAL), a biopharmaceutical company based in Denmark, announces that its partner, Sanofi has released additional positive results from the global GetGoal Phase III development program with Lyxumia® (lixisenatide) for the treatment of Type 2 diabetes. Lixisenatide was invented by Zealand Pharma and global rights are with Sanofi.
Top-line results from the GetGoal-L study showed that lixisenatide as an add-on therapy to basal insulin (with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c levels (p=0.0002) without significantly increasing the risk of hypoglycemia (p=0.14) versus placebo for patients with Type 2 diabetes. In addition, patients treated with lixisenatide had significantly improved postprandial plasma glucose after a test meal (p<0.0001). Patients in the lixisenatide arm of the study also reported a significant reduction in body weight (p<0.0001). The trial was a randomized (double-blind), placebo-controlled study with a 24-week main treatment period and comprising a total of 495 patients.
As expected with a GLP-1 drug, the most commonly reported adverse event with lixisenatide was nausea, which was associated with a low rate of discontinuation.
GetGoal-L is the fifth of nine studies to report positive data within the GetGoal Phase III clinical program, and the second study after GetGoal-L Asia to investigate the benefits of lixisenatide 20µg once-daily combined with basal insulin, including Lantus®. The results confirm those previously reported, and this time in a broader population including both Caucasian and Asian patients.
The full study results from GetGoal-L are planned to be presented at a future medical congress. Commenting on today’s announcement, David Solomon, President and Chief Executive Officer of Zealand Pharma, said: “We are delighted that lixisenatide, now officially named Lyxumia®, has generated another set of positive Phase III results. The efficacy and safety data continues to be strong and supportive for the compound and the results from GetGoal-L represent a new important step for Zealand Pharma, further demonstrating the near-term value potential of Lyxumia® as an attractive new drug for Type 2 diabetes patients - as monotherapy or in combination with Lantus®.”
