Sanofi and Regeneron’s two Phase IIIb/IV trials of alirocumab meet primary endpoint

12th June 2017 (Last Updated June 12th, 2017 18:30)

Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase IIIb/IV DM-INSULIN and DM-DYSLIPIDEMIA clinical trials of Praluent (alirocumab) to treat patients with diabetes and hypercholesterolemia.

Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase IIIb/IV DM-INSULIN and DM-DYSLIPIDEMIA clinical trials of Praluent (alirocumab) to treat patients with diabetes and hypercholesterolemia.

Praluent is designed to prevent the binding of PCSK9 to the low-density lipoprotein (LDL) receptor, resulting in an increase of the number of LDL receptors available and a subsequent decrease of LDL cholesterol (LDL-C) levels in the blood.

Upon administration of the product on top of maximally tolerated doses (MTD) of statins, a significant decrease of LDL-C in DM-INSULIN trial and greater reduction in non-high-density lipoprotein cholesterol (non-HDL-C) during DM-DYSLIPIDEMIA trial were observed when compared to standard care.

The randomised, double-blind, placebo-controlled, parallel-group, multi-centre DM-INSULIN trial evaluated 75mg of Praluent for every two weeks in 517 type 1 and type 2 diabetes patients, who were on insulin with high cardiovascular (CV) risk, hypercholesterolemia and took MTD statins.

"The primary endpoint of the trials was percentage change in calculated LDL-C or non-HDL-C from baseline to week 24."

During the trial, the dose was changed to 150mg every two weeks at week 12, in the case of patients with LDL-C greater than or equal to 70mg/dL at week eight.

In the randomised, open-label, parallel-group, multi-centre, multi-national DM-DYSLIPIDEMIA trial, the superiority of Praluent was assessed in 413 type 2 diabetes and mixed dyslipidemia patients who were at high-CV risk that is not properly controlled with MTD statins.

The dose in this trial was adjusted if the patients’ non-HDL-C was greater than or equal to 100mg/dL at week eight.

In DM-INSULIN, up to 80% of patients reached their lipid goals, while a total of 64% reached their goals in the DM-DYSLIPIDEMIA trial.

The primary endpoint of the trials was percentage change in calculated LDL-C or non-HDL-C from baseline to week 24.

Praluent was found to be well-tolerated, with an overall safety profile comparable with other trials in the ODYSSEY Phase III programme.