Genzyme, Isis begin second Phase III cholesterol drug study

WASHINGTON Two companies have begun a second Phase III study of a drug designed to lower “bad” LDL cholesterol.

Researchers from Genzyme and Isis Pharmaceuticals are enrolling about 100 patients who have both coronary heart disease and heterozygous familial hypercholesterolemia, a genetic disease that causes high levels of LDL cholesterol, to partake in the study using the drug mipomersen.

The United States Patent and Trademark Office has granted the two companies a patent for the drug’s method of action to lower lipids, known as antisense technology.

The study is randomized, double-blind and placebo-controlled and will take place at around 30 sites in the U.S. and Canada. The companies also hope to start three more studies among high-risk patient groups by the end of the year.