ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ: ESPR) reported more positive “top-lline” results from the lates study of the effectiveness and safety of its ETC-1002 cholesterol drug in a Phase 2b human study.
Esperion is working on drugs that can be administered by pill to treat high cholesterol and other cardiac risk factors. They operate in a new way for people who may be intolerant to today’s statin drugs.
The latest study evaluated ETC-1002 alone compared to current therapy in patients both with and without excess side effects from taking statin drugs.
Esperion said the 12-week study met its goal by cutting low-density lipoprotein, the so-called bad cholesterol, by 27 percent and 30 percent respectively at doses of 120 and 180 milligrams. The results were “significantly different” than the other drug studied, ezetimibe. Combining ETC-1002 with etizimbe produced a reduction of 48 percent.
Esperion said the reductions occurred within the first two weeks of dosing and continued throughout the treatment period.
Esperion said ETC-1002 monotherapy and ETC-1002 in combination with ezetimibe also demonstrated significantly greater reductions than ezetimibe in high-sensitivity C-reactive protein, an important marker of inflammation in coronary disease.
“Many people with hypercholesterolemia are not able to control their LDL-cholesterol levels with currently available therapies. This is especially true for patients who are statin intolerant because they have limited therapeutic options,” said Paul Thompson, M.D., medical director of cardiology and The Athletes’ Heart Program, Hartford Hospital. “ETC-1002 has the LDL-cholesterol lowering of a mid-dose statin and is well-tolerated, and could benefit these patients.”
ETC-1002 appeared to be safe and well-tolerated. Discontinuation rates due to adverse events with ETC-1002 were comparable to those seen with ezetimibe. Rates of adverse events and serious adverse events were low and comparable across treatment groups. Elevations in liver enzymes were as expected and comparable to what is typically observed with approved LDL-cholesterol lowering therapies. In patients treated with ETC-1002, including those with statin intolerance, rates of muscle-related AEs were similar to those seen with ezetimibe.
Said Tim M. Mayleben, Esperion president and CEO: “Our ability to show significant differences between ETC-1002 and ezetimibe in both LDL-cholesterol lowering and reductions in hsCRP demonstrate the potential of ETC-1002 as a new oral therapeutic option for patients with hypercholesterolemia, especially those with statin intolerance. The similarity in muscle-related adverse events between ETC-1002 and ezetimibe is especially encouraging.”
To listen to a replay of a Thursday afternoon conference call discussing the results, visit www.esperion.com.