Navigation Links
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 due to AEs was in line with historic lipid-lowering trials.

Separately, the company further announced the allowance of a US patent covering DCCR. The patent entitled "Salts of potassium ATP channel openers and uses thereof" contains claims to salts of diazoxide - including DCCR - as well as pharmaceutical formulations of such salts. Additional applications filed in the US and globally will further enhance the patent portfolio of Essentialis.

Commenting on these developments, Essentialis President and CEO, Dr Iain Dukes said, "Essentialis has convincingly demonstrated the therapeutic utility of DCCR as a triglyceride lowering agent with a superior profile to existing approved drugs. The issuance of the patent covering DCCR provides timely coverage for its future commercial development."

Pivotal phase 3 protocols for very high triglycerides and phase 2 protocols for statin combination therapy are currently being finalized with input from experts and the FDA in parallel with partnering discussions.

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. Compositions 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, Lovaza and fenofibrate, while effective, also cause significant elevations in LDL-cholesterol.

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 has completed Phase 2 studies in dyslipidemic subjects. The company is actively exploring partnering arrangements for DCCR and its portfolio of follow-on and back-up compounds.


'/>"/>
SOURCE Essentialis
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Essentialis Completes Patient Enrollment in Phase 2 Trial of DDCR for Treatment of Dyslipidemia
2. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
3. ERBITUX(R) Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study
4. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
5. Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migraine Headache
6. A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
7. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
8. Second Phase III Study of Avastin in 1st Line Metastatic Breast Cancer Meets its Primary Endpoint
9. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
10. Abbotts Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
11. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2017)... 10, 2017  The tenth annual BioPharm America™ ... at the Sheraton Boston Hotel, September 26–27. ... to global decision makers and innovative biotech startup companies. ... leaders during two impactful days. BioPharm America is now ... additional networking opportunities with 4,500+ life science industry influencers ...
(Date:7/5/2017)... 2017 Oramed Pharmaceuticals Inc. (NASDAQ: ... ), a clinical-stage pharmaceutical company focused on the development of ... approval from the Israel Securities Authority to dual-list its common ... stock will commence trading on the TASE on July 12, ... capitalization of the Company, it is expected that Oramed will ...
(Date:6/30/2017)... ROCKVILLE, Md. , June 30, 2017 ... that since the start of May, at least ten ... financings include private investments, public offerings and a loan ... $3.3 million to almost $80 million.  Kalorama Information provides ... customers of its Diagnostics Knowledge Center. ...
Breaking Medicine Technology:
(Date:7/24/2017)... , ... July 24, 2017 , ... ... office at 2307 Bellmore Avenue, Bellmore, New York, (516) 784-5858. The office opened ... M.D. and physician assistants Lori Friedman and Fruma Leah Wiederman. , Advanced ...
(Date:7/24/2017)... ... 24, 2017 , ... “Nana Nana Boo Boo”: a delightful tale of a ... “Nana Nana Boo Boo” is the creation of published author Michael Rush, a Deputy ... Faith Publishing, Michael Rush’s new book presents the importance of manners in a way ...
(Date:7/24/2017)... ... ... “Journey to the Light: The Quest for Happiness and Love. . . through Faith”: ... “Journey to the Light: The Quest for Happiness and Love. . . through ... manuals, and articles, who has recently decided to expand her literary horizons and write ...
(Date:7/23/2017)... Alexandria, Virginia (PRWEB) , ... July 24, 2017 ... ... during the American Association of Physicists in Medicine (AAPM) 59th Annual Meeting & ... , Members of the medical physics profession, hospital administrators and journalists can visit ...
(Date:7/23/2017)... ... July 23, 2017 , ... A 20-year-long study by a national ... the Minneapolis Veterans Administration Health Care System overwhelmingly supports growing evidence that prostate cancer ... benefits. , In the cases involved with this study, surgery did not prolong ...
Breaking Medicine News(10 mins):