Ionis announces third investigational antisense medicine to treat nonalcoholic steatohepatitis (NASH) enters development

CARLSBAD, Calif., Nov. 23, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that the biopharmaceutical company AstraZeneca has licensed ION455, an investigational antisense medicine being developed as a potential treatment for nonalcoholic steatohepatitis (NASH). ION455 is the second medicine for the treatment of NASH that Ionis has partnered with AstraZeneca. The companies have also partnered on ION839 (AZD2693), which is designed to inhibit the production of patatin-like phospholipase domain-containing 3 (PNPLA3) protein, a major genetic determinant of NASH progression. Separately, Ionis is also developing a wholly owned NASH program. ION224 is designed to reduce the production of DGAT2, or diacylglycerol acyltransferase 2, for treating patients with NASH. ION224 is one of more than 20 medicines in the growing Ionis-owned pipeline that the company is prioritizing and preparing for commercialization.

NASH is the most severe form of nonalcoholic fatty liver disease (NAFLD). It is related to the epidemic of obesity, pre-diabetes and diabetes. Unlike liver disease caused by alcohol consumption, NAFLD is the result of an accumulation of fat in the liver, which can lead to inflammation and cirrhosis, an advanced scarring of the liver that prevents the liver from functioning normally. About 20 percent of NASH patients are reported to develop cirrhosis and 30 to 40 percent of patients with NASH cirrhosis experience liver-related death.i Currently, a liver transplant is the only treatment for advanced cirrhosis and liver failure. Because of the high prevalence of NASH, it has recently become the third most common indication for liver transplantation in the U.S.

“Today, there are no FDA-approved medicines to specifically treat nonalcoholic steatohepatitis. However, due in large part to the progress made by our cardio-metabolic franchise, three Ionis-discovered novel medicines are now in development. These are encouraging advances that we hope will one day bring therapeutic benefit to patients who have limited treatment options,” said Brett P. Monia, Ph.D., Ionis’ chief executive officer. 

ION455 is the fourth medicine to reach development in partnership with AstraZeneca. Ionis earned $30 million from AstraZeneca for licensing ION455 and is eligible to earn up to $300 million in milestone payments plus royalties on net sales. AstraZeneca will have responsibility for further development of ION455, including regulatory filings, and commercialization.

In addition to NASH, Ionis and AstraZeneca are collaborating on potential treatments for kidney disease, cardiovascular disease and cancer.

Ionis’ Forward-looking Statement

This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of ION455, ION839 (AZD2693), ION224 and Ionis’ technologies and products in development. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for

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Cites Link to Nonalcoholic Fatty Liver Disease and Importance of Early Detection

Echosens, a high-technology company offering the FibroScan family of products, urges increased awareness of the rise of liver cancer rates, which have more than tripled since 1980, while death rates have more than doubled during this time. About 21,000 Americans are diagnosed with primary liver cancer each year—twice as common in men than in women. Risk factors include other liver diseases, including cirrhosis, chronic hepatitis B, chronic hepatitis C and non-alcoholic fatty liver disease (NAFLD). NAFLD may be a key driver of increased cancer associated with obesity, while non-alcoholic steatohepatitis (NASH) is the fastest growing cause of liver cancer among transplant candidates.

“People with NAFLD have higher rates of several types of cancer, with the greatest increase seen for liver cancer and other gastrointestinal cancers,” says Jon Gingrich, CEO, Echosens North America. “Point-of-care examinations, monitoring and ongoing assessment of liver fat and stiffness as provided by FibroScan, a rapid, non-invasive point of care examination, can identify individuals who are asymptomatic and undiagnosed for liver damage.”

Researchers have found that liver cancer, NAFLD, hepatitis C and liver transplants are prevalent in 40-80% of people who have Type 2 diabetes and in 30-90% of people who are obese. Being overweight or obese is responsible for about 85% of fatty liver disease.

“Approximately 30,000 people die from liver cancer each year and these numbers have continued to rise in recent years,” says Lynn Gardner Seim, Executive Vice President and Chief Operating Officer, American Liver Foundation. “It is essential that patients at risk for liver cancer, including those who have previously been diagnosed with hepatitis C, NAFLD, NASH and other liver diseases, talk with their doctors and have a plan in place for getting screened.”

Traditional approaches to assessing liver health, such as liver biopsy and advanced radiological imaging, may not be cost effective nor accessible to the broader at-risk population. FibroScan directly measures physical properties of stiffness and fat liver to provide reproducible results and allow for both diagnosis and monitoring of liver stiffness and liver fat. It is also recognized worldwide as the reference for non-invasive liver diagnosis supported with more than 2,000 medical publications and 40 guideline recommendations.

About Echosens

Echosens, the developer of FibroScan®, is an innovative high-technology company offering a full range of products and services supporting physicians in their assessment and management of patients with chronic liver diseases. FibroScan is supported by over 2,500 peer-reviewed publications and examinations are covered by Medicare, Medicaid and many insurance plans. For more information, please visit http://www.echosens.us and follow us on Twitter (@echosensNA).

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Contacts

Media:
Brittany Tedesco
CPR Communications
[email protected]
201.641.1911 x 14

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