Akero's drug reduces fatty liver scarring in mid-stage trial

[March 04, 2024]  (Reuters) -Akero Therapeutics' drug to treat a type of fatty liver disease helped significantly reduce scarring after nearly two years in a study, it said on Monday, as the company targets a potential multi-billion-dollar market.

The company's shares were last up 33% in premarket trading after nearly doubling in value initially.

Akero was testing its lead drug in a mid-stage trial for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a huge unmet need in the U.S.

The condition, earlier called non-alcoholic steatohepatitis (NASH), affects around 5% of the population, according to the American Liver Foundation, but has no approved drugs after numerous failures over the last few years.

After 96 weeks, biopsies of patients showed that Akero's drug, efruxifermin, helped reduce scarring in the liver by at least one stage in 75% of patients who took the higher dose, and in 46% of those on the lower dose, compared to 24% for placebo.

The rates of reduction by one stage in scarring was higher at 96 weeks than that at 24 weeks, showing sustained improvement due to the drug.

Over a third of the patients on the higher dose and 31% on the lower dose showed at least two stages of reduction in scarring, compared to just 3% on placebo, the company said.

The reduction in scarring at the higher dose are the largest response rates reported publicly to date in any MASH population, said Stephen Harrison, medical director of Pinnacle Clinical Research and principal investigator for the study.

The U.S. Food and Drug Administration is expected to decide on Madrigal Pharmacauticals' drug resmetirom by March 14, and an approval could make it the first to cater to the market.

NeuroBo Pharmaceuticals and 89bio are also developing treatments for the disease, while Eli Lilly last month said tirzepatide, the active ingredient in its blockbuster weight-loss and diabetes drugs, also helped patients with MASH.

Akero's shares were trading at $36.99 before the bell.

(Reporting by Leroy Leo and Puyaan Singh in Bengaluru; Editing by Shailesh Kuber and Sriraj Kalluvila)

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