Milestone! NASH new drug once a week subcutaneous injection, significantly improve liver fibrosis! Akero shares surged 135%

On September 13, Akero Therapeutics announced that Efruxifermin had obtained positive data in the Phase IIb HARMONY study, with both the Efruxifermin 28 and 50 mg dose groups achieving primary endpoints for improving liver fibrosis as well as multiple secondary endpoints

Affected by this news, the company's stock price rose by 135%

Nonalcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease characterized by excessive accumulation of fat in the liver, stress and damage to liver cells, inflammation and fibrosis, which in turn progresses to cirrhosis, liver failure, cancer and even death

Designed by mimicking the bioactivity profile of natural FGF21, Efruxifermin extends the half-life by fusing Fc while replacing certain amino acids

HARMONY is a multicenter, randomized, double-blind, placebo-controlled Phase IIb study designed to evaluate the efficacy and safety of Efruxifermin in patients with NASH

Specifically, at week 24, both the Efruxifermin 28 mg and 50 mg dose groups met the primary endpoints of the study, with 39% and 41% of patients achieving at least one stage of improvement in liver fibrosis and NO NASH deteriorating, compared to only 20%

The study also met a key secondary endpoint, with 47 percent and 76 percent of patients receiving Efruxifermin 28 mg and 50 mg, respectively, achieving NASH relief without worsening liver fibrosis, compared to 15 percent

The Efruxifermin group achieved statistically significant improvements

Efruxifermin was well tolerated, no treatment-related deaths occurred, and the most common adverse events were diarrhea, nausea, and increased

"We believe the results of the HARMONY study are an important milestone, not only for Akerero, but for the entire NASH field