Omthera Pharmaceuticals announced that Phase 3 results from its EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) and ESPRIT (Epanova combined with a Statin in Patients with HypertRiglycerIdemia to Reduce Non-HDL CholesTerol) clinical trials for Epanova met all primary and secondary endpoints.
The EVOLVE trial, a 12 week, multi-center, randomized, double-blind study of 399 patients, evaluated the efficacy and safety of three doses of Epanova in patients with fasting TG levels of at least 500mg/dL but <2000mg/dL. Patients were randomized into four dosing groups: Epanova 2g/day; Epanova 3g/day; Epanova 4g/day; and control (olive oil 4g/day). The study reached its primary endpoint of TG reduction (measured as a percentage change from baseline to Week 12) as well as its secondary endpoint of Non-HDL-C at all doses. Specifically, Epanova:
- demonstrated highly statistically significant reduction of TG in all dose groups, with decreases in TG from baseline to end of treatment of approximately 26% (P<0.01) in the 2 gram cohort and 31% (P<0.001) for subjects on the 4 gram dose.
- demonstrated statistically significant reduction in Non-HDL-C in all dose groups, with decreases in Non-HDL-C of approximately 8% (P<0.05) in the 2 gram cohort and 10% (P<0.01) in the 4 gram cohort. Non-HDL-C is widely viewed as the most accurate predictor of cardiovascular disease.
- produced statistically significant reductions in multiple, established markers of atherogenicity (ie, cardiovascular risk). Of note, treatment with Epanova yielded an approximate 11% (P<0.05) reduction in ApoC-III among subjects in the 2 gram cohort and an approximate 14% (P<0.001) reduction among subjects in the 4 gram cohort.
- showed substantially higher dose-dependent increases in plasma levels of EPA and DHA, confirming the superior bioavailability of this free fatty acid formulation versus the ethyl ester form found in other prescription Omega 3 products.
ESPRIT, a six-week, randomized, double-blind, parallel group study of 647 patients, assessed the efficacy and safety of add-on Epanova to statin therapy in patients with persistent hypertriglyceridemia and high risk for cardiovascular disease. Patients were randomized into three dosing groups; Epanova 2g/day; Epanova 4g/day; and control (olive oil 4 g/day). The study met its primary endpoint, a percentage change in Non-HDL-C from baseline to Week 6, as well as its secondary endpoints, including a percent change in TG and HDL-C from baseline to Week 6.
Specifically, the study showed that Epanova (2g or 4g daily), when added to statin monotherapy:
- demonstrated a statistically significant reduction in Non-HDL-C in all dose groups, with decreases in Non-HDL-C from baseline to Week 6 of approximately 4% (P<0.05) in the 2 gram cohort (comparable to doubling the statin dose) and approximately 7% (P<0.001) for subjects in the 4 gram cohort (comparable to tripling the statin dose for patients).
- demonstrated a statistically significant reduction in TG in all dose groups, with decreases in TG of approximately 15% (P<0.001) in the 2 gram cohort and 21% (P<0.001) for subjects in the 4 gram cohort.
- demonstrated a statistically significant reduction in VLDL-C of 14% with the 2 gram dose and a decrease of 22% with the 4 gram dose. LDL-C increased 5% with the 2 gram dose (5mg/dL, P<0.05) and showed a 1% increase in LDL-C (1mg/dL, NS) with the 4 gram dose. Non-HDL-C is primarily comprised of VLDL-C and LDL-C.
- produced significant reductions in multiple, established markers of atherogenicity. Specifically, at the 2 gram dose, Epanova yielded an approximate 8% (P<0.065) reduction in ApoC-III, and an approximate 13% (P<0.0001) reduction in ApoC-III at the 4 gram dose.
- significantly increased plasma levels of EPA and DHA with both doses of Epanova.
Epanova is a novel, ultra-pure mixture of the free fatty acid forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
For more information call (908) 741-4399 or visit www.omthera.com.