Oct 1 (Reuters) - A new type of experimental cholesterol fighter being developed by Esperion Therapeutics Inc lowered LDL levels significantly more than Merck & Co Inc’s Zetia in a midstage clinical trial, the company said on Wednesday.
In the 12-week study involving 348 patients with high LDL cholesterol the Esperion drug, ETC-1002, led to an average 30 percent reduction in levels of the “bad” cholesterol for those who received a 180 milligram dose and a 27 percent reduction with a 120 mg dose, according to initial results.
Both were deemed to be statistically significant differences compared with reductions experienced by patients taking Zetia, known chemically as ezetimibe, the company said.
The LDL reductions seen with the once daily ETC-1002 pill were somewhat less than can be achieved by the more powerful statins, such as Pfizer Inc’s Lipitor, now available as generic atorvastatin, and AstraZeneca Plc’s Crestor. It was roughly half of the LDL lowering magnitude seen with new injectable biotech cholesterol drugs, called PCSK9 inhibitors, likely to be approved next year.
The Esperion drug, when combined with 10 mg of Zetia, led to LDL reductions of 48 percent for the high dose of ETC-1002 and 43 percent with the lower dose.
“These are very encouraging results. It basically shows efficacy, and it shows that it can be added to ezetimibe to get more efficacy,” Dr. Christie Ballantyne, chief of cardiology at Baylor College of Medicine in Houston and one of the study’s investigators, said in a telephone interview.
“Statins are going to stay first line drugs,” he said. “There’s lots of people who a have hard time taking a high dose of statin or taking a statin at all.”
If approved, the Esperion drug is almost surely going to be less expensive than the more effective biologics, making it a potential option that physicians could reach for before putting patients on the injectables, Ballantyne said.
Esperion is also conducting trials combining its drug with various statins.
ETC-1002 also led to significantly greater reductions than Zetia in C-reactive protein, a marker of inflammation associated with heart disease, the company said.
ETC-1002 is the first in a new class of drugs called ACL inhibitors that work by reducing cholesterol synthesis in the liver and increasing expression of LDL receptors that remove cholesterol from the blood.
The most common side effects were common cold symptoms and upper respiratory tract infections. The rates of muscle-related adverse side effects seen with ETC-1002 patients, including those with statin intolerance, were similar to rates for Zetia, Esperion said. (Reporting by Bill Berkrot. Editing by Andre Grenon)