AKRO - Akero stock soars 71% as drug improves liver fibrosis prevents disease worsening in trial

Akero Therapeutics ( NASDAQ: AKRO ) said its drug efruxifermin (EFX) improved liver fibrosis without the worsening of liver disease, meeting the main goal of a Phase 2b study.

The trial, dubbed HARMONY evaluated two dose levels, 50mg in 34 people and 28mg in 38 people of EFX, against placebo (in 41 people) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), fibrosis stage 2 or 3 (F2-F3).

The study met its primary goal for both the 50mg and 28mg EFX dose groups, with 41% and 39% of EFX-treated patients, respectively, seeing  at least a one-stage improvement in liver fibrosis with no worsening of NASH by week 24, compared with 20% for the placebo group, the company said in a Sept. 13 press release.

The study also met a key secondary goal with 76% of patients treated with 50mg and and 47% of those on 28mg, achieving NASH resolution without worsening of fibrosis, compared to 15% for placebo, the company noted .

Akero added that 41% of patients on 50mg and and 29% on 28mg, achieved both goals (NASH resolution and fibrosis improvement ?1 stage), compared to 5% on placebo.

Despite indicators of more advanced disease, the study also showed statistically significant effects in multiple secondary goals in both dose groups, including improvements in liver fat, liver enzymes, non-invasive fibrosis markers, HbA1c (blood sugar level), lipoproteins, and body weight, according to the company.

Akero said a single drug-related serious adverse event (SAE) of esophagitis (inflammation of esophagus) was experienced by a patient in the 50mg group who had a history of gastroesophageal reflux disease. Three other SAEs were reported as unrelated to study drug.

Five patients on EFX were discontinued due to adverse events (AEs) (two in the 28mg group and three in the 50mg group, one of which was reported to be unrelated to study drug), compared to none for placebo, the company added.

EFX was reported to be generally well tolerated. Across both dose groups, the most frequent AEs were grade 1 or 2 gastrointestinal events, such as diarrhea, nausea, increased appetite, and frequent bowel movements.

Akero said it expects to report data from an ongoing phase 2b study called SYMMETRY — in patients with NASH with compensated cirrhosis (F4), Child-Pugh class A — in H2 2023.

NASH is a disorder in which there is inflammation and liver damage, along with fat in the liver.

AKRO +71.07% to $20.99 premarket Sept. 13

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