Sanofi presents positive results with Lyxumia and Lantus in type 2 diabetes at EASD meeting

French drug major Sanofi (Euronext: SAN) has reported positive results from the GetGoal-F1 study with Lyxumia (lixisenatide). Lixisenatide is a once-daily GLP-1 receptor agonist discovered by Denmark’s Zealand Pharma (OMX: ZEAL) and licensed to Sanofi, which is completing clinical Phase III development of the drug for the treatment of type 2 diabetes.

Under the agreement with Sanofi, Zealand Pharma is eligible to receive remaining milestone payments of up to $235 million and low double-digit royalties of worldwide sales of both Lyxumia and combination products including lixisenatide. The French group expects to file for approval of the drug by March 2012, it said recently (The Pharma Letter September 7). Sanofi aims to position the drug with its insulin Lantus (insulin glargine; see also below) and Lyxumia is seen as a possible blockbuster which could help the drugmaker reach its goal of becoming the world's top diabetes treatment company.

The objectives of GetGoal-F1 were to compare the efficacy and safety of lixisenatide (20mcg once-daily) versus placebo in one-step and two-step dose increase regimens in type 2 diabetes patients uncontrolled on metformin. Lixisenatide achieved the primary efficacy endpoint of significant HbA1c reduction with both dosing regimens. Sanofi will present the study findings on September 14 in a poster session at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.
Top-line results show that lixisenatide significantly reduces HbA1c from baseline to week 24 in both treatment regimens, compared with placebo (one-step: -0.92%; two-step: -0.83% versus placebo: -0.42%; p<0.0001). The percentage of patients reaching HbA1c targets of ≤ 6.5% and < 7.0% was 25.6% and 47.4% with the one-step regimen and 20.4% and 42.1% with the two-step regimen versus 7.6% and 24.1% with placebo, respectively. In addition, both one- and two-step regimens reduced body weight: one-step, 2.63kg (p=0.0042) and two-step, 2.68kg (p=0.0025), versus placebo, -1.63kg.