Navigation Links
Essentialis Completes Patient Enrollment in Phase 2 Trial of DDCR for Treatment of Dyslipidemia
Date:11/23/2008

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
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Vical Completes Enrollment and Reports Positive Interim Data in CMV Vaccine Phase 2 Trial
2. ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
3. Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial With Intravenous Delivery of JX-594 Oncolytic Virus
4. Regado Biosciences Completes Patient Enrollment for Phase IIa Study of REG1 Anticoagulation System
5. Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
6. Peregrine Pharmaceuticals Completes Patient Enrollment in First Stage of Its Second Bavituximab Phase II Breast Cancer Trial
7. VIA Pharmaceuticals Completes Patient Visits in Phase 2 Acute Coronary Syndrome (ACS) Trial
8. Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval
9. Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
10. Merck Serono Completes Enrollment in the REFLEX Trial of Rebif(R) in Patients at Risk of Developing Multiple Sclerosis
11. CuraGen Completes Enrollment in Phase II Trial of CR011-vcMMAE in Metastatic Melanoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... June 23, 2016 , , ... July 7, 2016 , , , , LOCATION: , , ... , , , EXPERT PANELISTS:  , , , Frost & ... Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, ... The global pharmaceutical industry is witnessing an exceptional era. Several new ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing ... which patients and their families pay tribute to a genetic counselor by nominating him ... Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
Breaking Medicine News(10 mins):