The LisiLan-L Phase III clinical trial has now met its primary endpoints in patients affected by type 2 diabetes who are currently treated with insulin glargine combined with metformin and without it. The ratio for the combination is fixed at 100 units/ml of insulin glargine and lixisenatide, a GLP-1 receptor which has demonstrated superior reduction (statistically) in HbA1c (average of blood glucose during the 3 previous months) compared to insulin glargine 100 units. Full results of the trial will be communicated in a future scientific forum. That trial involved patients whose T2D was not adequately controlled on metformin or metformin and another oral antidiabetic agent.
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LixiLan a drug developed with Danish drugmaker Zealand Pharma along with Sanofi’s Lantus, consists of a lethal single-injection combo of Lyxumia. Overall, LixiLan had a safety profile reflecting those of insulin glargine 100 units/mL and lixisenatide.
A few months ago, in July, Sanofi had declared that the combination drug’s first late stage Phase III study had showed significantly effective results. 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.
The successful completion of the LixiLan-L trial does not change Zealand’s financial guidance for 2015, which includes expected milestone payments from license partners of up to DKK 155 million (EUR 21 million).
Under Zealand’s agreement with Sanofi for Lixisenatide and Lixilan, responsibility for the entire development and commercialization process including financing rests with Sanofi.
Image: Sanofi Global R&D president Elias Zerhouni.
Zealand has invented lixisenatide, a once-daily prandial GLP-1 agonist, which is marketed globally (ex-US) by Sanofi for the treatment of Type 2 diabetes.
Good news has come to light recently, however, as Sanofi’s LixiLan diabetes drug has succeeded in achieving its goals during a second late-stage Phase III study, and is therefore ready for regulatory submission later this year, according to Reuters.
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The company is based in Copenhagen (Glostrup), Denmark.
