CARLSBAD, Calif., Nov. 23 CA-EssentialisComplet
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."
About DCCR
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.
About Essentialis
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
