Essentialis receives patent for active component in DCCR product

Essentialis, Inc. announced today that the United States Patent & Trademark Office (USPTO) has issued U.S. Patent No. 7,799,777 entitled Salts of potassium ATP channel openers and uses thereof. The patent claims a novel composition of a polymorph of diazoxide choline, the active ingredient in the Essentialis lead product, DCCR.  Essentialis has successfully completed phase 2b clinical trials with DCCR, showing a highly significant triglyceride reduction in dyslipidemic patients.

"The granting of this patent further secures our intellectual property position on the active component in DCCR", said Aaron Berg, Chief Commercial Officer of Essentialis.  "This patent combined with our previously issued patents provide Essentialis with broad patent protection on our drug active, pharmaceutical formulations, methods of use and methods of manufacturing DCCR which currently extends to 2028."  

DCCR is the first product in a new class of dyslipidemia treatment, with a mechanism of action distinct from other dyslipidemia treatments.  In Phase 2b clinical studies, DCCR has demonstrated the potential to lower triglycerides (30-50%), non-HDL cholesterol and Apo B (10-15%) while raising HDL-cholesterol (5-10%). DCCR reduces the production of triglyceride rich lipoprotein particles before they can accumulate and contribute to the progression of pancreatitis and cardiovascular disease. Currently available dsylipidemia treatments (such as fibrates and omega 3 fatty acid products) work primarily by increasing clearance of triglycerides from the blood stream.

"DCCR's unique mechanism of action will allow for additive efficacy with statins and other lipid-lowering agents to better achieve desired lipid targets," said Neil Cowen, Ph.D., Co-founder and Chief Scientific Officer for Essentialis.  "Once a patient maximizes their benefit from one agent, additional therapeutic benefit may be achieved with DCCR, helping them reach lipid goals."

Patients taking DCCR experience mostly mild to moderate, transient adverse events, the most frequent of which included increases in fasting plasma glucose that are similar to or less than those seen with niacin, another lipid-lowering drug, peripheral edema similar to what is seen with calcium channel blocking antihypertensives, and headaches.