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Phase 2b Trial Shows Unique Lipid Efficacy Profile of Novel Compound to Reduce Elevated Triglyceride Levels
Date:2/29/2012

SAN DIEGO, Feb. 29, 2012 /PRNewswire/ -- Essentialis, Inc., today announced Phase 2b trial results for its investigational compound DCCR demonstrating a reduction in triglyceride (TG) levels by 30 to 40 percent in patients whose TG levels exceeded 500 mg/dL (Very High Triglycerides [VHTG]). The study included an arm combining DCCR with fenofibrate treatment (Abbott Laboratories' Trilipix® (fenofibric acid)); in the combination arm, DCCR was shown to be additive to fenofibrate for all lipid fractions except LDL-C. In contrast, a 2009 study of VHTG patients using prescription omega-3 fatty acid in combination with fenofibrate revealed no clinically important change compared to fenofibrate alone(1).

More than five million people in the United States have very high TG levels. This population is at elevated risk for a number of diseases, including acute pancreatitis, diabetes and cardiovascular events (e.g., sudden death, myocardial infarction, acute coronary syndrome, revascularization, stroke and atrial fibrillation).

"The results of this study contribute to the growing body of knowledge on the potential of DCCR as a triglyceride-lowering treatment," said Richard C. Pasternak, M.D., Essentialis board member and head of the Company's scientific advisory board. "These data clearly motivate us to advance DCCR into larger trials that may demonstrate benefit to patients with multiple disease risk factors."

In this Phase 2b double-blind, placebo-controlled study, subjects were included in one of two sub-groups. About half of the subjects were included in the atorvastatin combination sub-group, where they were randomized to receive either DCCR 290 mg or placebo in combination with atorvastatin (Pfizer Inc.'s Lipitor®) 20 mg for 18 weeks. The remaining subjects in the study were included in the monotherapy/fenofibrate combination subgroup, where they were randomized to receive either DCCR 290 mg or placebo for 12 weeks, followed by co-adm
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SOURCE Essentialis, Inc.
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