Pharmaceutical

First-in-class cholesterol drug faring well in clinical trials

lipitor 435x435 First in class cholesterol drug faring well in clinical trialsA first-in-its-class cholesterol-lowering drug is plowing through clinical trials and appears to lower LDL levels significantly more than Merck & Co’s Zetia.

ETC-1002 is an oral pill made by Esperion Therapeutics. It is the first in a new class of cholesterol-lowering drugs known as ACL inhibitors. They work by reducing cholesterol synthesis in the liver and increasing LDL receptors that remove cholesterol from the blood.

ETC-1002 was pitted against Zetia in a 12-week study involving 348 patients with high LDL, considered the “bad” cholesterol. ETC-1002 reduced LDL an average of 30 percent in patients who received a 180-milligram dose and 27 percent in those who received a 120-milligram dose. Both were considered statistically significant compared to reductions in LDL in patients taking Zetia, known chemically as ezetimibe.

ETC-1002 also fared well when combined with 10 milligrams of Zetia, giving a 48 percent reduction for patients taking the higher dose of ETC-1002 and 43 percent reduction with the lower dose.

Despite the positive results, the drug is not expected to perform as well as statins, such as the widely prescribed Lipitor. The results are also not as impressive as those seen with new injectable biotech cholesterol-lowering drugs called PCSK9 inhibitors, the first of which are expected to be approved next year. But they may be better tolerated than statins. Common side effects with ETC-1002 include upper respiratory tract infections. Muscle-related adverse events were about the same as patients taking Zetia.

Statins, however, are not tolerated well by many patients. The drugs can cause muscle pains and weakness making exercise difficult. They have been linked to muscle injury and liver damage. They can also drive up blood sugar levels, increasing the risk for type 2 diabetes.

Source: Reuters