[Corrected 10/25/18, 5:26 p.m. See below.] The competition to develop a treatment for nonalcoholic steatohepatitis, a serious liver disorder, has another player. 89Bio launched Thursday with $60 million in financing and a lead compound originally developed by Teva Pharmaceutical. [Paragraph updated to correct dollar amount.]
San Francisco-based 89Bio says that it has acquired a pipeline of biologic and small molecule drug candidates from Teva (NYSE: TEVA). The most advanced of the lot is BIO89-100, an experimental treatment for nonalcoholic steatohepatitis (NASH) that is currently in Phase 1 testing.
NASH is a severe form of fatty liver disease that leads to liver damage. Fatty liver disease affects between 30 percent and 40 of adults in the U.S., according to estimates cited by the National Institute of Diabetes and Digestive and Kidney Diseases. Of those, about 20 percent have NASH, which can lead to cirrhosis and liver failure. Severe cases require patients to undergo a liver transplant. The exact cause of NASH isn’t known, but it is more commonly found in those who are obese, as well as in patients who have type 2 diabetes. The FDA has yet to approve any drugs to treat NASH, though doctors have recommended weight loss to reduce fat in the liver and mitigate damage to the organ.
The NASH compound that 89Bio acquired from Teva is a version of fibroblast growth factor 21 (FGF21), a protein that has been studied as a drug target. According to published research, FGF21 regulates the body’s metabolism of fat and reduces its accumulation in the liver. The exact cause of NASH isn’t known, but it is more commonly found in those who are obese, as well as in patients who have type 2 diabetes.
89Bio says its drug was developed using technology that prolongs the half-life of FGF21, and optimizes the activity of the FGF21 protein that is native to the liver. The company points to other potential benefits of its drug, based on findings from preclinical studies, such as improved measures of body weight, blood glucose, and lipids. Also, the longer half-life of the compound could support extended dosing of the drug, the 89Bio says.
NASH has drawn research interest from big pharmaceutical companies and emerging biotechs. Some of them are taking an approach similar to 89Bio’s. Bristol-Myers Squibb (NYSE: BMS) drug BMS-986036, currently in mid-stage testing, is also a version of FGF21, as is AKR-001 from startup Akero Therapeutics, which licensed its lead drug from Amgen (NASDAQ: AMGN). Other companies that have NASH drugs in clinical trials include Gilead Sciences (NASDAQ: GILD) and Madrigal Pharmaceuticals (NASDAQ: MGDL).
89Bio will use the new capital to continue its development of the drug candidates that were acquired from Teva, including a preclinical compound that it says also has potential applications in NASH and other related disorders. In addition to its San Francisco headquarters, 89Bio says it will maintain an R&D site in Israel.
The Series A round of financing was led by Orbimed Israel and OrbiMed US, which founded San Francisco-based 89Bio, and Longitude Capital. Other investors disclosed in the round were RA Capital and Pontifax.