Esperion Therapeutics Inc (ESPR) hit a home run with top-line results from ETC-1002-008, a 12-week Phase 2b study that is one of the largest ever conducted with statin intolerant patients. The study evaluated the efficacy and safety of ETC-1002 monotherapy compared with ezetimibe (Zetia) monotherapy in patients with hypercholesterolemia, with or without statin intolerance. The study met its primary endpoint – greater LDL-cholesterol lowering from baseline with ETC-1002 compared with ezetimibe. On the conference call, Esperion management stated that the results exceeded even their expectations, and that the drug will be “friendly” to patients, physicians, and payers alike.
ESPR climbed 30% in after-hours trading on Wednesday.
ETC-1002 as a monotherapy produced 27% and 30% reductions in LDL-cholesterol at 120mg and 180mg doses, respectively. These reductions were significantly different from ezetimibe alone (p=0.0008 and p< 0.0001, respectively). A combination of 120mg of ETC-1002 and 10mg ezetimibe, LDL-cholesterol reductions reached 43%, and a combination of 180mg of ETC-1002 and10 mg ezetimibe, generated a 48% LDL improvement.
The findings are transformational for ETC-1002 and Esperion: differences between ETC-1002 and ezetimibe were shown in both LDL-cholesterol lowering and reductions in hsCRP. Perhaps the main positive takeaway is that the results were equally as positive for the statin intolerant as they were for the statin tolerant. Paul Thompson, M.D., Medical Director of Cardiology and The Athletes’ Heart Program, Hartford Hospital, advised that “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,” Dr. Thompson further added that “ETC-1002 has the LDL-cholesterol lowering of a mid-dose statin and is well-tolerated, and could benefit these patients.”
Esperion had cash and equivalents of $66.8 million at the end of the second quarter and expects the balance to last into early 2016.
