Akero picks up $65M to advance Amgen-licensed NASH drug

People think about NASH as a metabolic or antifibrotic treatment area, CEO Jonathan Young said. AKR-001 covers both. (pasja1000)

Akero Therapeutics raised $65 million in series A financing to advance its lead program, long-acting fibroblast growth factor 21 (FGF21) analog, for the treatment of nonalcoholic steatohepatitis (NASH).

The Cambridge, Massachusetts-based biotech licensed the candidate, known as AKR-001, from Amgen on the strength of early clinical data. It has been studied through phase 1 in diabetic patients, and Akero plans to bring it through phase 2 in patients with NASH, said Akero CEO Jonathan Young, Ph.D.

People with nonalcoholic fatty liver disease store excess fat in the liver. Some of these patients go on to develop NASH, in which the fat buildup causes inflammation and damage, which can in turn cause liver scarring, or fibrosis.

People think about NASH as a metabolic or antifibrotic treatment area, Young said. AKR-001 covers both. 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, Akero Chief Scientific Officer Tim Rolph, D.Phil., said.

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Rolph previously worked on FGF21 at Pfizer. The protein plays a key role in regulating metabolism and signaling throughout the body—“it is recruited naturally to protect against cellular stress and restore metabolic balance,” the company said in a release. But the native protein’s half-life is only about half an hour. Akero’s 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, Rolph said.

While Akero’s initial focus is NASH, the company said it will also evaluate the potential of AKR-001 in treating other metabolic diseases.

“We designed the financing to have flexibility to look at additional indications for some of these exploratory endeavors,” Young said. “We have latitude to bring additional external assets to diversify the pipeline, but our focus is NASH.”

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The financing was led by Apple Tree Partners, Atlas Venture, venBio Partners, and Versant Ventures.

To say NASH is a hot field would be an understatement. In April this year, AstraZeneca licensed a NASH drug from Ionis, and Eli Lilly offloaded all of its NASH candidates to Terns Pharmaceuticals. And in May, Madrigal saw its stock jump 130% on midstage NASH results for an old Roche drug.