A novel new oral medication by Esperion Therapeutics designed to lower cholesterol levels to help protect against heart disease is making its way through clinical trials, and analysts say it is a compound that should be taken seriously. The reason? Esperion founder Roger Newton was one of the key players in the development of Lipitor (atorvastatin), the widely used cholesterol-lowering statin medication made by Pfizer.
Statins are commonly prescribed to patients with elevated cholesterol levels and have shown to be effective. However, they can carry potentially serious side effects including muscle pain leading to muscle injury as well as liver damage.
The drugs can also raise blood sugar levels, putting patients – especially postmenopausal women – at risk for type 2 diabetes. Because of the side effects, many patients simply cannot tolerate the medication and are left with few options.
The new compound, known simply as ETC-1002, has shown promise in phase 2 clinical trials, including ETC-1002 in diabetic patients with high cholesterol and as an add-on to statins in patients with high cholesterol.
ETC-1002 works by inhibiting cholesterol synthesis in the liver much the way statins do but at an earlier stage than statins. It is designed for people with high cholesterol who cannot tolerate side effects of statin medication.
In the latest trial, patients were randomized to increasing doses of ETC-1002 or placebo for eight weeks. Patients who were given the compound had a 32 percent reduction in LDL compared to a three percent drop in patients given a placebo. The drug also appeared to be well-tolerated among participants.
Several weeks ago, Esperion initiated a large phase 2b clinical study in both statin-intolerant and statin-tolerant patients. The compound will be given during a period of 12 weeks as either a stand-alone treatment or in combination with the statin Zetia (ezetimibe). Early results are expected late next year.