In pre-market trading, shares of Akero Therapeutics Inc. (Nasdaq: AKRO) were up 77.67% to $21.80 after encouraging clinical trial data were announced. In Monday’s session, AKRO stock gained 4.78% to close at $12.27 with 0.68 million shares changing hands.
AKRO has shared what?
Today, Akero Therapeutics (AKRO) released topline data from its HARMONY trial. A 24-week phase 2b study is being conducted by AKRO to evaluate the safety and effectiveness of efruxifermin (EFX) as a potential treatment for precirrhotic nonalcoholic steatohepatitis (NASH) and fibrosis stage 2 or 3 (F2-F3).
By week 24, EFX-treated patients experienced reductions in liver fibrosis across a one-stage improvement across both 50mg and 28mg dose groups, compared with placebo-treated patients showing no worsening of NASH by week 24.
As a secondary endpoint, 76% of patients who received 50mg and 47% of patients who received 28mg of the drug were able to resolve NASH without worsening fibrosis, compared with 15% for those who received placebo. Furthermore, 41% and 29% of patients treated with 50mg and 28mg, respectively, were able to resolve NASH and improve fibrosis, compared to 5% of placebo-treated patients.
AKRO’s HARMONY study showed statistically significant improvements in histological characteristics, in addition to strong secondary endpoint results, suggesting that EFX may be effective in treating NASH at its core. EFX could potentially serve as a foundational monotherapy for patients suffering from NASH based on the magnitude and consistency of results observed in the Phase 2a and Phase 2b BALANCED studies.
There were several characteristics of patients in the HARMONY study that were suggestive of high progression risk. There was a mean weight of 105 kilograms across all dose groups. NASH and Type 2 diabetes were common among patients in all dose groups. The HARMONY study found that twice as many patients had fibrosis stage 3 (66%) as fibrosis stage 2 (34%).
What impact will this have?
As a consequence of the HARMONY study, Akero Therapeutics (AKRO) and the entire NASH community have reached an important milestone. A substantial and growing health burden in the US and Europe is caused by NASH as it is the leading cause of liver transplants and liver cancer. AKRO’s data is very compelling and shows EFX’s potential to address both the metabolic drivers of disease and the inflammation and fibrosis that occur later on in disease progression.