Mixed Phase 3 results for Sanofi and UCB
pharmafile | July 29, 2015 | News story | Research and Development | LixiLan, Sanofi, UCB, clinical trials, epratuzumab, insulin, insulin glargine, phase III
Two drugs that pharma companies are pinning hopes on for future success have had mixed outcomes in key late-stage clinical trials.
Sanofi’s new insulin, LixiLan, met its primary endpoint in a Phase III trial, however two Phase III studies of UCB Pharma’s investigation lupus drug epratuzumab did not show clinical benefits.
Sanofi’s Phase III trial looked at its latest insulin glargine product, LixiLan-O, a once-daily single injection of a combination of insulin glargine and lixisenatide, The study compared LixiLan with either Lyxumia (lixisenatide) or insulin over 30 weeks, in 1,170 patients with type 2 diabetes that was treated but not controlled.
Over three months the combination of insulin glargine and Lyxumia – a GLP-1 receptor agonist which is jointly marketed by Sanofi and Zealand Pharma – reduced average blood glucose more than Lyxumia and insulin glargine alone.
An ongoing safety study in 736 patients is expected to end in the third quarter of 2015, and following an analysis of results from both III studies, Sanofi is expected to file for regulatory approvals in the US later in the fourth quarter of 2015 and in the EU in the first quarter of 2016.
In 2013 Sanofi withdrew its FDA application for LixiLan, after the regulator raised concerns about interim data on the drug’s cardiovascular outcomes.
The collaboration has been a lucrative one for Zealand Pharma, however. Sanofi has filed a new drug application with the FDA for Lyxumia, and in the company’s quarter 2 results it revealed it has paid Zealand royalties on global sales of Lyxumia outside of the US of €1.0 for the period 1 April to 30 June 2015. This corresponds to an increase of 65% over the same period in 2014 and an increase of 12% over the previous quarter.
“Meeting the primary objective of this important Phase III study highlights the potential clinical value of this investigational therapeutic option,” says Dr Elias Zerhouni, president of global R&D at Sanofi. “We look forward to advancing the LixiLan program and bringing this combination of insulin glargine and lixisenatide to patients.”
However UCB suffered a major setback after its potential lupus drug epratuzumab disappointed in late-stage trials, having shown promise at earlier stages of clinical research.
Two Phase III clinical studies of epratuzumab in 1,574 people with systemic lupus erythematosus (SLE) did not meet their primary clinical efficacy endpoints at either dose looked at in both studies. Patients given epratuzumab did not show a statistically significantly higher response than those who received a placebo and standard therapy.
Professor Iris Loew-Friedrich, chief medical officer and executive vice president at UCB, says: “Although we are disappointed with the results from the Phase 3 program, our commitment to the lupus community remains. We are focused on developing new therapies for the treatment of immunological conditions including SLE and have another SLE drug in clinical development. The news does not alter UCB’s strategy as we remain committed to delivering value for patients living with lupus and other immunologic diseases.”
Lilian Anekwe
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