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Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US
Date:5/17/2009

CARLSBAD, Calif., May 17 /PRNewswire/ -- Essentialis Inc, a clinical stage pharmaceutical company, announced today that it met its primary endpoint of statistically significant triglyceride reduction in a 90-patient Phase 2b trial of DCCR in dyslipidemic patients. The study encompassed both patients with very high triglycerides and mixed dyslipidemia and included normal weight, overweight and obese patients presenting with or without hypertension.

The randomized, double-blind study, which was powered as if it were pivotal, assessed the drug's effect on dyslipidemia and evaluated three different doses of DCCR given over an 8-week period compared to placebo. The study included 90 subjects with high and very high triglycerides as well as subjects on stable doses of statins. At the end of 8 weeks, treatment with DCCR resulted in a 30% placebo-adjusted median reduction in triglycerides. The reduction was clinically relevant, highly significant and competitive with existing approved drugs. In subjects with very high baseline triglycerides, DCCR treatment resulted in a substantially greater reduction in triglycerides. In contrast to the effects of Lovaza and fenofibrate - the current gold standard medicines for treating hypertriglyceridemia - no meaningful increase in LDL-C was observed in DCCR-treated subjects, irrespective of baseline triglyceride levels. In subjects with elevated LDL-C at baseline, DCCR treated subjects experienced a fall in LDL-C. Reductions in non-HDL-C and total-C were also observed in DCCR treated subjects together with a modest rise in HDL-C. In subjects on steady doses of statins, the effects of DCCR appeared to be additive to statin therapy. Weight and waist circumference reduction, blood pressure lowering, LFT and insulin resistance improvements were also demonstrated. DCCR was generally well tolerated, and most of the AEs were mild to moderate, resolving without sequelae. There were no SAEs and the discontinuation rate
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