A new type of lipid-lowering drug being developed by Sanofi and Regeneron Pharmaceuticals cut cholesterol levels by about half in its first late-stage clinical trial, the companies will announce on Wednesday.
The drug, called alirocumab, is one of a new class of potentially powerful cholesterol fighters that have excited doctors and investors alike, spurring a heated race to market among Sanofi, Amgen, Pfizer and other companies.
The results of the latest study appear to be consistent with those of previous, smaller studies. But they are expected to be closely scrutinized — for both effectiveness and safety — because they are from the first Phase 3 trial of one of the new medicines, which are called PCSK9 inhibitors.
Dr. George D. Yancopoulos, chief scientific officer of Regeneron, said there were no serious drug-related safety problems in the trial.
"The drug continues to look promising," he said in an interview. "There are not red flags. There are not problems that are holding this up."
Still, this trial was only the first of 12 that Sanofi and Regeneron were conducting for alirocumab, and the data had not been peer-reviewed. It was also a small trial, involving only 103 patients.
Half of the patients received alirocumab — injecting themselves once every two weeks. The other half received Merck's pill Zetia, also known as ezetimibe.
After 24 weeks, the level of so-called bad cholesterol had dropped an average of 47.2 percent for those taking alirocumab, but fell only 15.6 percent for those taking Zetia.
Of the 52 patients taking alirocumab, 14 had to increase their dose midway through the trial because their cholesterol level had not dropped enough, Dr. Yancopoulos said.
The study was designed to see if alirocumab might be an alternative treatment for people who cannot tolerate Lipitor or other statins, the mainstay drugs used to lower cholesterol.
Sanofi and Regeneron are conducting other studies to see if their drug could be added to statins to lower cholesterol even more. One big study will seek to answer whether the drug, in addition to lowering cholesterol, could actually prevent heart attacks and strokes. Dr. Yancopoulos said Regeneron and Sanofi hoped to submit their application for approval of the drug by the end of 2015.
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