Just six months after bagging a $65 million series A, Akero Therapeutics is at it again. The company has reeled in $70 million in its B round that will push its lead asset, a treatment for nonalcoholic steatohepatitis (NASH) licensed from Amgen, through phase 2. Akero will also build out its metabolic disease pipeline and boost its manufacturing capabilities.
Akero’s lead asset, AKR-001, is an analog of long-acting fibroblast growth factor 21 (FGF21), a hormone involved in regulating metabolism and signaling in the body. It is “recruited naturally to protect against cellular stress and restore metabolic balance,” the company says. But native FGF21 has a short half-life—only about half an hour—and would require frequent dosing. AKR-001 is designed to confer the benefits of native FGF21, but with a half-life of three to four days, which supports once-weekly dosing, said Akero Chief Scientific Officer Tim Rolph, D.Phil., in a previous interview.
What differentiates AKR-001 from other treatments in development is that it targets the downstream symptoms of NASH while also tackling the underlying cause of the disease, Rolph said.
“With specific potency at receptors FGFR1c, 2c and 3c but not FGFR4, AKR-001 is expected to reduce liver fat, cellular stress, inflammation and fibrosis in patients with NASH and to improve risk factors of cardiovascular disease, reducing triglycerides and non-HDL cholesterol,” Akero said. The company plans to start phase 2 studies of the drug in mid-2019.
Akero has made it plain that its priority is NASH, but the Cambridge, Massachusetts-based company is looking to expand its pipeline in metabolic disease. It may not need to look further than AKR-001 to add another indication. A pair of phase 2 trials found once-weekly doses of the treatment improved insulin sensitivity and lipoprotein markers in patients with Type 2 diabetes, Akero said. Beyond AKR-001, the company may look for other treatments to in-license.
“We designed the financing to have flexibility to look at additional indications for some of these exploratory endeavors. We have latitude to bring additional external assets to diversify the pipeline, but our focus is NASH,” said Jonathan Young, Ph.D., in June, when he was Akero CEO. With the appointment of former Gilead Chief Medical Officer Andrew Cheng as CEO in September, Young transitioned to the COO role.
Akero’s series A backers Apple Tree Partners, Atlas Venture, venBio Partners and Versant Ventures returned for the B round. They were joined by Redmile Group, Boxer Capital of Tavistock Group, Cormorant Asset Management, BVF Partners, Rock Springs Capital, and LifeSci Venture Partners.
"The breadth and strength of our investor syndicate is a reflection of the enthusiasm for Akero's focus on metabolic disease, and the potential of our lead asset to address liver pathology in patients with NASH," said Cheng, M.D., Ph.D.