Navigation Links
Essentialis to Submit SPA for Hypertriglyceridemia

CARLSBAD, Calif., Aug. 11 /PRNewswire/ -- Essentialis, Inc., a clinical stage pharmaceutical company, announced today its intention to file a Special Protocol Assessment (SPA) with the FDA for the pivotal study to support the NDA filing on its lead drug, DCCR, for the treatment of very high triglycerides. The proposed study would include 280 randomized subjects with the primary efficacy endpoint assessed at 12 weeks. This decision followed a productive Type C meeting with the FDA on July 30th, where the overall development plan for DCCR and the non-clinical package supporting the NDA were reviewed and discussed. Commenting on this development, Essentialis President and CEO Iain Dukes stated, "The submission of the SPA will bring us one step closer towards filing for approval of DCCR for the treatment of patients with very high triglycerides. This development, along with positive Phase 2 study results and the recent issuance of a US patent providing extensive protection to DCCR, underscores the tremendous clinical and commercial potential of this drug worldwide."

About DCCR

DCCR, diazoxide choline controlled release tablet, is an ATP-sensitive potassium channel agonist which has potential therapeutic utility in several cardiovascular and metabolic diseases. Extensive Phase 1 testing has demonstrated the drug's potential to lower triglycerides (TG), non-HDL cholesterol and LDL-cholesterol (LDL-C) while raising HDL-cholesterol. In addition, weight loss has been demonstrated in 2 investigator sponsored studies. A Phase 2, 8-week, placebo-controlled, double-blind study involving 90 patients, which was powered to be pivotal, demonstrated statistically significant reductions in triglycerides, without impacting LDL-C. In subjects with elevated LDL-C at baseline, DCCR reduced LDL-C levels. DCCR was generally well tolerated, and most AEs were mild to moderate, resolving without sequelae. US patent 7,572,789, containing claims to DCCR, was issued on August 11, 2009. Additional applications filed in the US and globally will further enhance the patent portfolio. Phase 2 and pivotal studies of DCCR in combination with a statin for the treatment of high triglycerides (TG between 200 and 500 mg/dL) are planned, and study synopses have been provided to the FDA.

About Hypertriglyceridemia

Very high triglycerides (TG greater than or equal to 500mg/dL) are a risk factor for developing pancreatitis. There are approximately 3.8 million patients in the US with very high triglycerides. The leading products for treating very high triglycerides are fenofibrate and omega-3 fatty acids. While effective, these compounds cause significant elevations in LDL-C. High triglycerides (TG between 200 and 500 mg/dL) are a risk factor for coronary heart disease even after LDL-C targets have been achieved.

About Essentialis, Inc.

Essentialis, Inc. is a pharmaceutical company based in Carlsbad, CA. The Company's products are 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, DCCR, is set to commence pivotal studies in subjects with very high triglycerides. Essentialis is actively exploring its partnering options for DCCR.

SOURCE Essentialis, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US
2. Essentialis Completes Patient Enrollment in Phase 2 Trial of DDCR for Treatment of Dyslipidemia
3. Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
4. Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
5. PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)
6. PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA
7. Human Genome Sciences Submits Biologics License Application to FDA for ABthrax(TM)
8. Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever
9. D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients
10. AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
11. U.S. Naval Medical Research Center Resubmits IND Application for Proposed RESUS Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
Post Your Comments:
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 Research and ... "Asia Pacific Cardiac Pacemaker Market Outlook to 2019 - ... Drive the Demand " report to their offering. ... --> Boston scientific and others. ... global players including Medtronic, Biotronik, Boston ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
(Date:11/26/2015)... , November 26, 2015 ... Juntendo universitetssjukhus ser potential att använda ... magnetresonansbilder (MR-bilder) för patienter med multipel ... ett forskningsavtal med SyntheticMR AB för att ... forskningsprojekt på sjukhuset. Med SyMRI kan man ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... A team of ... ways to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Hospital Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy ...
(Date:11/27/2015)... ... 27, 2015 , ... ProSidebar: Fashion is a set of 30 ... ProSidebar: Fasion, video editors can easily add an informative sidebar to any FCPX production. ... Utilize presets featuring self-animating drop zones, lines, bars, and text with the ease of ...
(Date:11/27/2015)... ... 27, 2015 , ... The moment you stop improving is ... fulfilling the needs of advisers and clients but going above and beyond to ... customer service. However, there's always room for improvement, which is why the entire ...
(Date:11/27/2015)... ... 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces his ... is one of Joplin's most famous and beautiful concert posters. The concert was held ... Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's stardom ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... Travel Representative. As a franchise owner, Somu now offers travelers, value and care ... wedding packages, private cruise sales, as well as, cabin upgrades and special amenities ...
Breaking Medicine News(10 mins):