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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

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
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SOURCE Essentialis
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