Patent Covers Chronic Inflammatory Diseases such as Non-Alcoholic Steatohepatitis (NASH) and Chronic Kidney Disease (CKD)
August 14, 2014
La Jolla Pharmaceutical Company , a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a notice of allowance for patent application number 14/254,510 covering methods of treating chronic inflammation by intravenous administration of aqueous modified pectin solutions with molecular weights greater than 25 kilodaltons.
“We are pleased to have received these additional claims covering aqueous solutions of modified pectin with limited molecular weight restrictions for the treatment of chronic inflammation,” said James Rolke, Vice President of Research and Development at La Jolla and an inventor on the allowed patent application. “These newly allowed claims expand our proprietary position for the use of modified pectin as a treatment for organ diseases that result from chronic inflammation.”
The Company’s intellectual property portfolio includes several issued and pending patents for the treatment of chronic inflammation. These issued and pending patents provide or will provide proprietary coverage for the Company’s pectin-based drugs, GCS-100 and LJPC-1010, as well as other modified pectin materials, including all modified pectins currently in clinical development.
Pectins are high molecular weight, complex polysaccharides that can be obtained from multiple sources (e.g., citrus, apple, etc.), all of which share a common basic structure comprising a block co-polymer of 1,4-linked galacturonic acid and 1,2-linked rhamnose with side branches of either 1,4-linked β-D-galactose or 1,5-α-linked L-arabinose. In addition, some portion of the galacturonic acid backbone can be esterified or exist as the uronic acid salt.
GCS-100 is a complex polysaccharide derived from pectin that binds to, and blocks the activity of, galectin-3, a type of galectin. Over-expression of galectin-3 has been implicated in a number of human diseases, including chronic organ failure and cancer. La Jolla is developing GCS-100 for the treatment of chronic kidney disease (CKD). In March of 2014, La Jolla announced top-line results from its randomized, placebo-controlled Phase 2 clinical trial of GCS-100 in severe CKD, in which the predefined primary efficacy endpoint was met. La Jolla completed enrollment for a Phase 2 extension clinical trial of GCS-100 in patients with severe CKD in June of 2014 and plans to initiate a Phase 2b clinical trial in late 2014.
LJPC-1010 is a more potent and purified derivative of GCS-100 that can be delivered orally. The Company is developing LJPC-1010 for the treatment of nonalcoholic steatohepatitis (NASH). NASH is the more serious form of nonalcoholic fatty liver disease, or NAFLD, which can lead to liver failure. In July of 2014, La Jolla announced positive preclinical data of LJPC-1010 in NASH. La Jolla plans to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) and initiate a Phase 1 clinical trial of LJPC-1010 in NASH in early 2015.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. LJPC-501, La Jolla’s lead product candidate, is a proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. GCS-100, La Jolla’s second product candidate, is a first-in-class inhibitor of galectin-3 for the potential treatment of chronic kidney disease. LJPC-1010, La Jolla’s third product candidate, is a more potent and purified derivative of GCS-100 that can be delivered orally for the potential treatment of nonalcoholic steatohepatitis. LJPC-401, La Jolla’s fourth product candidate, is a natural peptide for the potential treatment of iron overload. For more information on La Jolla, please visit http://www.ljpc.com.