BioPharma, Startups

OrbiMed launches 89Bio with $60M Series A round to develop Teva’s NASH drug

The new company is headquartered in San Francisco, with R&D in Israel and has launched a Phase I study of BIO89-100, formerly TEV-47948.

graphic design of a liver

Several US and Israeli venture capital firms have provided a round of financing for a new company that is developing treatments for an increasingly problematic form of fatty liver disease, taking on a pipeline of drugs from Israel’s largest drugmaker.

89Bio announced its launch Thursday with $60 million in Series A funding. OrbiMed’s Israeli and US divisions – which both founded 89Bio – led the round, along with Menlo Park, California-based Longitude Capital. RA Capital Management and Pontifax also participated. The new company is headquartered in San Francisco, with research and development operations in Herzliya, Israel.

The company is developing a drug called BIO89-100, currently in Phase I development for nonalcoholic steatohepatitis, or NASH. The drug, originally called TEV-47948, was acquired from Teva Pharmaceutical Industries, along with other biologic and small-molecule assets that 89Bio is developing. The drug is a long-acting glycopegylated fibroblast growth factor 21, or FGF21 analogue, which is designed to prolong the half-life and optimize the biological activity of native FGF21.

“NASH is a common and complex multifactorial disease linked to obesity and Type 2 diabetes, for which there are no approved treatments,” said Dr. Arun Sanyal, a gastroenterology and hepatology specialist at Virginia Commonwealth University, in a statement on behalf of the company. “FGF21 is a compelling target for intervention.”

Despite the lack of approved therapies, several companies have sought to address the disease. For example, Glympse Bio raised $22 million in a Series A round to develop NASH drugs earlier this month.

NASH is an advanced form of non-alcoholic fatty liver disease, or NAFLD, that can potentially read to life-threatening cirrhosis. As its name suggests, it results not from alcohol consumption, but from being overweight or obese, having insulin resistance of Type 2 diabetes, high levels of lipids in the blood and metabolic syndromes, according to the National Institute of Diabetes and Digestive Kidney diseases. According to an epidemiology study published last year, Asia has led the global rise in NAFLD, though the US follows closely behind, with prevalence rising from 15 percent in 2005 to 25 percent in 2010.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

A market forecast report two months ago from ResearchAndMarkets.com found that NASH in particular will become the leading cause of liver transplantation in the US in the coming years, but poor diagnosis due to a lack of ideal diagnostic technologies will limit the market’s growth. The NASH market, valued at $1.17 billion last year, is fast to grow to $21.47 billion by 2025.

Photo: eranicle, Getty Images