89Bio has raised $60 million to advance a stable of small molecules and biologics acquired from Teva, including an FGF21 analog for nonalcoholic steatohepatitis (NASH) that’s currently in phase 1. The biotech also signed on Rohan Palekar, who helmed CNS-focused Avanir Pharmaceuticals until 2017, as its CEO.
The biotech’s lead candidate, BIO89-100—previously known as TEV-47948—is a long-acting analog of glycopegylated fibroblast growth factor 21 (FGF21), a protein that plays a key role in regulating metabolism and signaling throughout the body. The half-life of native FGF21 is only half an hour. BIO89-100 was developed using proprietary glycopegylation technology to extend the half-life and activity of the native protein.
"NASH is a common and complex multifactorial disease linked to obesity and Type 2 diabetes for which there are no approved treatments," said Arun Sanyal, M.D., a professor of gastroenterology and hepatology at the Virginia Commonwealth University, in a statement. "FGF21 is a compelling target for intervention. Given its metabolic role across multiple organs, BIO89-100 has the potential of affecting the disease pathway in both metabolic and fibrosis endpoints."
89Bio isn’t the only biotech working on an FGF21 analog; in June, Akero Therapeutics raised $65 million to advance its own candidate, licensed from Amgen. AKR-001 has been studied through phase 1 in people with diabetes, and Akero plans to study it through phase 2 in NASH patients. It has a half-life of three to four days, which makes it suitable for once-weekly dosing, said Akero Chief Scientific Officer Tim Rolph, D.Phil., at the time.
89Bio has another undisclosed compound that’s currently in preclinical studies that has “potential utility in the treatment of NASH and other related disorders.”
OrbiMed Israel, OrbiMed US and Longitude Capital led the series A, while RA Capital Management and Pontifax also participated. In addition to Palekar, the company also recruited a couple of former Teva executives. Michal Ayalon, Ph.D., who led the FGF21 program at Teva, will head up R&D at 89Bio, while Ram Waisbourd, previously vice president of strategy and transformation at Teva, joins as chief operating officer and chief business officer.