Akero Therapeutics Launches with $65 Million Series A to Battle NASH

Raising Money

Akero Therapeutics, headquartered in Cambridge, Massachusetts, closed on a $65 million Series A financing round. The round was co-led by Apple Tree Partners, Atlas Venture, venBio Partners and Versant Ventures. The company was founded by Apple Tree Partners.

The funds will be used to advance its lead clinical program, AKR-001, a novel, long-acting fibroblast growth factor 21 (FGF21) analogue. The compound as exclusively licensed from Amgen.

The drug is designed to treat non-alcoholic steatohepatitis, which is a disease similar to cirrhosis of the liver, but which occurs in people with little or no alcohol consumption. It is the most severe form of non-alcoholic fatty liver disease (NAFLD) and is characterized by an abnormal accumulation of fat in the liver, which can progress to liver cell injury and inflammation. It is related to the obesity and diabetes epidemics. At this time there are no specific treatments other than diet and exercise.

“NASH affects millions of people around the world and is only increasing in prevalence,” said Jonathan Young, Akero’s co-founder, president and chief executive officer, in a statement. “Akero’s FGF21 program addresses both the underlying disease drivers of NASH and downstream liver pathology and has the potential to be an important new treatment for a disease with no approved therapies.”

Research has identified the endogenous hormone FGF21 as playing a critical role in metabolism regulation and signaling. It acts on several organ systems, including the liver. The body recruits it naturally to protect from cellular stress and restore metabolic balance.

AKR-001 is a modified Fc-FGF21 fusion protein. “AKR-001’s unique profile as a balanced FGF21 agonist with multiple metabolic actions can potentially transform outcomes for NASH patients by resolving liver pathology,” said Timothy Rolph, company co-founder and chief scientific officer, in a statement. “AKR-001 acts on the liver and adipose tissue to reduce liver fat and suppresses inflammation.”

The company expects to launch a Phase II clinical trial of the compound.

Rolph told the Boston Business Journal that the buildup of fat causes stress to liver cells, which activates the immune system, which leads to “a vicious cycle of inflammation in the liver. It ultimately leads to the life being squeezed out of the liver. Our protein acts on all stages of the disease. It’s an ideal profile for a potential medicine for NASH.”

The company was founded in the spring of 2017. The company hasn’t announced a timetable for its Phase II trial. Young told the Boston Business Journal, “We want to build a lot of momentum around this first study … and make sure that we get it right. Based on the data we have to date, we believe we’re going to be at the forefront of programs in NASH.”

They’ll have plenty of competition. There are no approved drugs for a disease whose market is projected to be $25 billion by 2026. As a result, many companies are putting their resources into drugs. There are estimated to be approximately 195 drugs in the pipelines of a range of companies, including Terns Pharmaceuticals, which licensed three NASH programs from Eli Lilly. AstraZeneca, Takeda Pharmaceuticals, Allergan, and Gilead Sciences, have all invested in the space. In 2016, Allergan acquired multiple NASH pipeline products. In 2016, Bristol-Myers Squibb dropped $100 million to acquire rights for a NASH program from Japanese company Nitto Denko Corporation. And in April, California-based MediciNova stopped a Phase II NASH clinical trial after an interim data analysis found its MN-001 I (tipelukast) had significant positive results in NASH and NAFLD with hypertriglyceridemia patients.

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