The United States Patent and Trademark Office (USPTO) has issued notice of allowance to La Jolla Pharmaceutical Company's patent application number 13/888,158 covering methods of treating chronic inflammation using modified pectin. Specifically, the patent, which expires in 2025 without taking into account patent term extension, provides proprietary protection for methods of treating chronic inflammation by administration of modified pectin with a molecular weight greater than 25 kilodaltons.
The company’s intellectual property portfolio also includes several issued patents covering various modified pectin compositions and methods for preparing biologically active modified pectins, as well as pending patent applications directed to additional modified pectin compositions and methods of use. Chronic inflammation is the hallmark of many serious, debilitating and prevalent conditions such as NASH and chronic kidney disease (CKD). The company’s lead product candidate GCS-100, which is covered by this issued patent, is being studied in a randomized, placebo-controlled phase II clinical study in patients with CDK. Data on the primary efficacy endpoint from this study is due to be released in March of this year.
“Chronic inflammation is the principal underlying cause of fibrosis in multiple chronic ailments such as kidney, liver, heart and lung disease,” said James Rolke, senior director of Research and Development at La Jolla and an inventor on the allowed patent application. “These newly allowed claims solidify our proprietary position for using modified pectin as a treatment for organ disease that results from chronic inflammation.”
La Jolla Pharmaceutical Company also announced confirmation of previously reported data demonstrating GCS-100 activity in a mouse model of NASH. When compared to placebo-treated control animals, GCS-100, showed a statistically significant reduction in liver fibrosis, a statistically significant improvement in the Non-Alcoholic Fatty Liver Disease (NAFLD) score and a statistically significant improvement in liver function as measured by the liver enzyme alanine transaminase (ALT), in some cases returning to near normal levels. The study was performed in collaboration with the Stelic Institute & Co. (Tokyo, Japan) using an established, benchmark preclinical STAM model for Non-Alcoholic Steatohepatitis-Hepatocellular Carcinoma (NASH-HCC).
“The results of this study confirm that GCS-100 is able to prevent and potentially reverse chronic liver disease through the remediation of fibrosis,” said James Rolke, “In addition, the significant improvement in liver function, fibrosis and NAFLD suggests a preservation of functional tissue which is a clear clinical objective and benefit.”
Pectins are high molecular weight, complex polysaccharides that can be obtained from multiple sources (e.g., citrus, apple), 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 ß-D-galactose or 1,5-a-linked L-arabinose. In addition, some portion of the galacturonic acid backbone can be esterified or exist as the uronic acid salt.
GCS-100, the company’s lead product candidate, is a modified pectin and is covered by the newly allowed claims and several other issued patents. GCS-100 is currently being tested in a phase II clinical trial in patients with chronic kidney disease.
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics for chronic organ failure and cancer.