MAT8800 for treatment of fatty liver disease

Our MAT8800 discovery program is focused on identifying and developing product candidates derived from omega-3 fatty acids for the treatment of prevalent liver diseases for which there are currently only limited therapeutic solutions available. We believe that our unique ability to produce and isolate highly concentrated omega-3 fatty acids that have demonstrated effects on liver enzyme levels and histology could yield product candidates which are particularly well suited to treat these diseases.

We have established a discovery program called MAT8800 to identify and develop product candidates derived from omega-3 fatty acids for the treatment of prevalent liver diseases for which there are currently only limited therapeutic solutions. Our development work indicated that certain omega-3 fatty acids may yield improvement in liver enzyme levels and liver histology. Accordingly, we have identified potential omega-3 fatty acid compositions to study in preclinical settings. This discovery program is focused on identifying and optimizing product candidates comprising omega-3 fatty acids as potential treatments for nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) or other hepatic conditions.

About NAFLD and NASH

There are currently no drugs approved for the treatment of NAFLD or NASH. Lifestyle changes and exercise to reduce body weight and treatment of concomitant diabetes and dyslipidemia are accepted as the standard of care as first-line treatment, but have not conclusively been shown to prevent disease progression, especially for NASH. Off-label medications reportedly used for these conditions include insulin sensitizers (e.g., metformin, pioglitazone), antihyperlipidemic agents (e.g., gemfibrozil), pentoxifylline, vitamin E and ursodiol. Given the increasing prevalence of NAFLD and NASH, the medical community perceives a rapidly growing need for adequate medical solutions for these conditions.

Nonalcoholic fatty liver disease, or NAFLD, is believed to be the most common chronic liver disease worldwide, affecting between 15 to 30% of the population. In the United States, the current prevalence rate is estimated at 24%, translating to roughly 75 million patients. The rate for NAFLD is higher in Hispanics than both European-origin and Afro-American origin genotypes. The disease is associated with the Western diet, which is rich in processed foods with high fat and sugar content. NAFLD is characterized by abnormally high levels of fat, primarily in the form of triglycerides, cholesterol and fatty acids, leading to excessive fat accumulation in the liver, resulting in an increased risk for developing insulin resistance, metabolic syndrome, type 2 diabetes, cardiovascular disease and liver cancer. Of the cardiovascular events resulting in death, NAFLD co-morbidity is thought to occur in 24% of all cases.

A subset of approximately 30% of NAFLD patients develop NASH, which is a more serious liver disease. In these patients, for reasons that are still not completely understood, the fat build-up in the liver induces chronic inflammation which leads to progressive fibrosis that can lead to cirrhosis, liver failure or death. NASH is currently diagnosed by liver biopsy. Other non-invasive methods for determining fibrosis, such as determination of liver stiffness by specific ultrasound techniques and blood-based biomarker diagnostic panels, are being evaluated as replacement treatments for performing liver biopsies.

Studies have shown that at least 15% of NASH patients will develop liver cirrhosis over a ten to 15 year period. In the United States, the most recent epidemiological studies have concluded that more than 12% of the general population has NASH, while approximately 2.7%, or more than eight million patients, have advanced liver fibrosis or cirrhosis due to the disease. In the past decade, the proportion of liver transplants attributed to NASH increased from 1% to 10%, establishing NASH as the third leading and a rapidly increasing indication for liver transplant in the United States. The epidemiological data from other developed countries in Europe and Japan are similar. NASH has also become a highly prevalent liver disease in developing countries such as India and China.

Matinas BioPharma is actively seeking partnering opportunities for its metabolic/cardiovascular development programs. To learn more about partnering with Matinas BioPharma, please contact us.