Sanofi And Regeneron's Alirocumab Ph3 Trials Met Primary Efficacy Endpoint

Published: Nov 20, 2014

Sanofi and Regeneron’s Alirocumab Ph3 Trials Met Primary Efficacy Endpoint

November 19, 2014

By Jessica Wilson, BioSpace.com Breaking News Staff

Sanofi and Regeneron Pharmaceuticals, Inc. today presented detailed results from six Phase III trials of its cholesterol drug alirocumab at the American Heart Association (AHA) Scientific Sessions in Chicago. The companies had announced in July that all the Phase III trials had met their primary efficacy endpoints of significantly reduced low-density lipoprotein cholesterol (LDL-C or “bad’ cholesterol) in patients at 24 weeks of treatment as compared to treatment with either active comparator or placebo.

“In these trials patients treated with alirocumab achieved significant and robust LDL-C reductions compared to baseline,” said Jennifer Robinson, the director of the Prevention Intervention Center and professor at the College of Public Health at the University of Iowa, in a statement. “New interim results from ODYSSEY LONG TERM provide further support for alirocumab's consistent safety profile, including in more than 500 patients who achieved LDL-C levels lower than 25 mg/dL.”

The six trials, named ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, assessed alirocumab, an investigational fully human monoclonal antibody that targets the protein PCSK9, in hypercholesterolemic patients. The patients in the study had a high cardiovascular (CV) risk, an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), and/or a history of intolerance to two or more statins.

In the six randomized, double-blind studies, the patients received alirocumab by self-administering a 1-mililter (mL) subcutaneous injection every two weeks. The six ODYSSEY trials, along with four other Phase III studies, included more than 5,000 patients who participated in the treatment for 24 to 104 weeks.

The significance of alirocumab arises from the fact that patients who cannot tolerate statins to lower their bad LDL cholesterol had success with alirocumab. In fact, according to an article in Reuters, alirocumab helped 10 times as many patients as Merck & Co. ’s Zetia, another drug designed for statin-intolerant patients.

“It's a more potent and more effective lipid lowering drug, getting patients to goal by a 10-fold higher amount. It just blows (Zetia) away,” Patrick Moriarty, the study's lead investigator, who presented the results at the American Heart Association scientific meeting in Chicago, told Reuters.

Alirocumab is part of a new class of drugs that works by blocking the naturally occurring protein called PCSK9, which prevents the liver from flushing LDL from the blood.

The companies plan to file for approval of alirocumab by the end of the year. Reuters reported that they might run into some trouble, however, due to a patent-infringement suit filed against them by Amgen.

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