CARLSBAD, Calif., Nov. 23 /PRNewswire/ -- Essentialis Inc, a clinical stage pharmaceutical company, announced today that it has completed enrollment in a 92-patient Phase 2 trial of DCCR in dyslipidemic patients. The study encompasses both patients with very high triglycerides and mixed dyslipidemia and includes normal weight, overweight and obese patients presenting with or without hypertension.
The randomized, double-blind study is designed to assess the drug's effect on dyslipidemia and will evaluate three different doses of DCCR given over an 8-week period. Randomization was stratified by Body Mass Index (BMI) and concurrent use of statin drugs. The endpoints of the study include measurements of the effect of treatment on triglycerides, total-cholesterol, LDL-cholesterol, HDL-cholesterol and non-HDL-cholesterol, compared to placebo. The effects of DCCR on body weight, blood pressure and liver function tests compared to placebo are also being assessed. A total of 16 patients have completed the study, and an additional 20 have completed the double-blind treatment phase. The last patient last visit is scheduled for January 30th, 2009. Top-line results are anticipated in late March, 2009.
Commenting on this milestone achievement, Essentialis President and CEO, Iain Dukes said, "Essentialis is now closer to understanding the ability of DCCR to treat both very high triglycerides and mixed dyslipidemia, delivering a competitive profile of across the board lipid improvements with the added potential benefit of weight loss."
DCCR, diazoxide choline controlled release, is an ATP-dependent potassium channel agonist with potential utility in several cardiovascular and metabolic diseases. Extensive Phase 1 testing and investigator-sponsored clinical studies have demonstrated the drug's potential to lower triglycerides, non-HDL cholesterol and LDL-cholesterol while raising HDL-cholesterol. In addition, placebo adjusted weight loss exceeding 5% in an 8-week placebo controlled study and 10% in a 6-month study has been demonstrated. Composition of matter, formulation and method of use patents for DCCR have been filed worldwide. A fixed dose combination product with a statin is under development.
About Very High Triglycerides
Hypertriglyceridemia, a disease where patients have high blood levels of triglycerides, is associated with increased risk of coronary heart disease even after LDL-cholesterol targets have been achieved. Very high triglycerides are associated with an increased risk of developing pancreatitis. There are approximately 5 million patients in the US with very high triglycerides. The leading products for treating very high triglycerides, fenofibrate and omega-3 fatty acids, while effective, also cause significant elevations in LDL-cholesterol.
About Mixed Dyslipidemia
The prevalence of mixed dyslipidemia (characterized by elevated triglycerides and low HDL-cholesterol), is currently more than 16 million patients in the US and is rising in tandem with the ongoing obesity epidemic. Treatment options are limited and the leading products are associated with tolerability issues including flushing, elevated liver enzymes and increased risk of rhabdomyolysis when used in combination with statin drugs.
Essentialis is a pharmaceutical company based in Carlsbad, CA focused on the development of breakthrough medicines for the treatment of cardiovascular and metabolic diseases. The company's portfolio of products is targeted at the ATP-sensitive potassium channel, a metabolically-regulated membrane protein whose modulation has the potential to impact a wide range of cardiovascular and metabolic diseases. The company's lead product is in Phase 2 studies in dyslipidemic subjects and is entering a Phase 1 study in type I diabetes mellitus subjects.
|SOURCE Essentialis Inc|
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