Ralph McDade, PhD, Myriad RBM's president, explained earlier this year how the precision medicine approach, pioneered in oncology, was finding its way into the cardiovascular arena, and that it could ultimately lead to develop of a risk panel that would make the ELIXA trial simpler and less costly.
Myriad RBM, a subsidiary of Myriad Genetics, today announced an agreement with the pharmaceutical manufacturer Sanofi to perform a biomarker analysis from blood samples gathered during the ELIXA trial, the cardiosvascular (CV) outcomes trial for lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist.
Results for ELIXA, the Evaluation of Lixisenatide in Acute Coronary Syndrome, were presented at the Scientific Sessions of American Diabetes Association in Boston in June 2015. Researchers found the diabetes therapy presented no CV benefit, but no risk either, and lixisentatide, which is available in Europe and Japan, is now part of a combination insulin-GLP-1 RA therapy pending approval before the FDA.
“We know that cardiovascular risk is higher in people with diabetes and that cardiovascular disease negatively affects treatment outcomes,” said Riccardo Perfetti, head of the Global Diabetes Medical Team for Sanofi.
“Sanofi is committed to further exploring cardiovascular disease in this patient population. The biomarker work with Myriad RBM will allow us to further develop a molecular understanding of the cardiovascular risks in people with type 2 diabetes (T2D). Biomarker profiling supports our goal of developing potentially innovative new treatments for patients.”
Since 2008, the FDA has required CV outcomes trials for all new diabetes and obesity therapies to ensure they are safe for patients who face higher-than-normal degrees of risk. These large, expensive trials produce enormous amounts of information on CV and microvascular effects as well. Today’s agreement will allow Myriad RBM to use approximately 5300 serum samples from the ELIXA trial to measure biomarkers that can predict CV and microvascular risk, both renal and retinal, for those with T2D. Terms of the deal were not disclosed.
“Biomarker profiling can support the accelerated development of potentially innovative targeted treatments for people with diabetes,” said Marc Pfeffer, MD, Dzau Professor of Medicine at Harvard Medical School and chair of the ELIXA Steering Committee. “I am pleased that Sanofi is supporting this work, which will provide new insights for better predicting cardiovascular risk in people with diabetes and hopefully improve the beneficial effects of therapies.”
Myriad RBM’s DiscoveryMAP platform was used in the Sanofi ORIGIN trial to identify biomarkers linked to CV events or death in those with prediabetes or newly diagnosed T2D. The ORIGIN trial was an extremely long and large randomized, controlled trial involving Sanofi’s mainstay insulin, Lantus, to show it had no positive or negative CV effects.
Myriad RBM confirmed these biomarkers using a different platform, CustomMAP, using samples from a different Sanofi trial, the HOPE trial. That trial involved a different drug, Rampiril, and found it significantly reduced CV events in high-risk patients with normal ejection fractions.
How will the use of data collected from the ELIXA subjects benefit patients and drug development? Ralph McDade, PhD, president of Myriad RBM, explained how in a commentary earlier this year for Evidence-Based Diabetes Management. The approaches pioneered in oncology are being pursed in the study of CV markers, he said, which could ultimately lead to the development of a CV risk panel that reduces the size and complexity of trials like ELIXA.
“Our ultimate goal is to provide accurate estimates of the risk of a future cardiovascular event in patients so that drug developers and physicians can tailor care and achieve better health outcomes,” McDade said.