La Jolla Pharma issued notice of allowance for patent

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.

"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."

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 2 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.

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").

According to the National Institute of Diabetes and Digestive and Kidney Diseases, NASH affects between 7 million and 17.5 million Americans.

In addition, an estimated 5.5 million Americans have chronic liver disease or cirrhosis.

Together, chronic liver disease and cirrhosis are currently the 12th leading cause of death, accounting for approximately 27,000 deaths annually, in the United States. Chronic Liver disease affects Americans of all ages and walks of life.

"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."

A full study report provided to the company by Stelic Institute is available on the company’s web site. In addition, updates will be posted as they become available.