Navigation Links
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-administration of fenofibrate (Trilipix) 135 mg for another six weeks.

In combination with statin, DCCR 290 mg resulted in placebo-adjusted median reductions in TG of 28%, in VLDL-C of 51%, in non-HDL-C of 16%, and an increase in HDL-C of 11% after 18 weeks of treatment. In statin treated subjects, there was no change in mean LDL-C; however, all statin-treated subjects with LDL-C > 100 mg/dL at baseline who received DCCR showed improvements in LDL-C.

In combination with fenofibrate, treatment with DCCR resulted in median reductions in TG of 78%, in non-HDL-C of 34%, and an increase in HDL-C of 38%.  DCCR was additive to fenofibrate for all lipid fractions except LDL-C.  The increase in LDL-C was lower in fenofibrate + DCCR (42%) than in fenofibrate + placebo (57%).

Through 18 weeks, treatment with DCCR resulted in nearly a 40% improvement in HOMA-IR, a measure of insulin resistance, and a reduction in median weight of more than 3 kilograms, compared to a worsening of HOMA-IR (+13%) and no change in median weight in the placebo-treated subjects. The incidence, severity and nature of adverse events in the DCCR arm were comparable to placebo.

"There is a significant unmet need within the patient community for a compound like DCCR," said Aaron D. Berg, President and Chief Executive Officer, Essentialis, Inc. "Patients with very high triglyceride levels often do not reach accepted targets with current agents. Our plans to pursue next steps with DCCR are clear – we want to help patients reduce medical risks associated with very high triglyceride levels."

(1) Roth, et al, "Prescription Omega-3 Fatty Acid as an Adjunct to Fenofibrate Therapy in Hypertriglyceridemic Subjects", J Cardiovascular Pharmacol (2009) 54:196-203

About DCCR

DCCR is a proprietary crystalline salt of diazoxide in a controlled-release, once-a-day tablet formulation. It is in development for patients with very high triglyceride (TG) levels. Essentialis has completed an End-of-Phase 2 meeting with the FDA and has obtained an SPA covering a pivotal study. Essentialis expects to initiate Phase 3 clinical trials in 2012. DCCR is covered by multiple issued US and granted EU patents, which provide composition of matter protection until 2028. Essentialis has evaluated DCCR in several double-blind, placebo-controlled studies which demonstrated that the drug was well tolerated and that statistical significance for various endpoints was achieved in patients with elevated triglycerides. More than 100,000 patient-years of treatment with diazoxide help support the acceptable safety of DCCR.

About Essentialis, Inc.

Essentialis is a San Diego-headquartered pharmaceutical company focused on the development of breakthrough medicines targeted to the ATP-sensitive potassium channel, a metabolically regulated membrane protein whose modulation has potential to treat and prevent a wide range of cardiovascular and metabolic diseases. For more information visit http://essentialistherapeutics.com/.

Contacts:

Kristie Kuhl
kkuhl@makovsky.com
212.508.9642

Or

Aaron Berg
aberg@essentialistherapeutics.com
858-964-5022

 


'/>"/>
SOURCE Essentialis, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
3. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
4. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
5. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
6. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
7. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
8. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
9. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)...  BioPharmX Corporation (NYSE MKT: BPMX) researchers were part ... way to use nonlinear optical imaging to confirm the ... A presentation ... how researchers from BioPharmX and the Wellman Center for ... suite of imaging techniques in what is called "Pharmacokinetic ...
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/10/2017)... Oct. 10, 2017  NDS received FDA 510(k) clearance in May ... battery-powered display stand specifically designed for endoscopy environments. An innovative secondary ... a clinical solution to support the improvement of patient outcomes, procedural ... ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... agency serving communities in the greater Dallas, Miami, and Raleigh regions, is organizing ... fighting to overcome a rare and deadly chromosome abnormality. , After struggling since ...
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important ... problem. Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed ... darkness or restricted lighting. As such, it eliminates the need to turn on a ...
(Date:10/13/2017)... , ... October 13, 2017 , ... PurhealthRX , ... Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize ... providing a CBD form that can be easily incorporated into liquid products, while reducing ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional ... action towards gender equality at their inaugural Summit in New York City in June. ... a social audience of over 3 million. To watch the Mobilize Women video, ...
Breaking Medicine News(10 mins):