Akero Therapeutics Inc. (NASDAQ: AKRO) has announced the completion of enrolment in the Phase 2b HARMONY trial of its novel FGF21, Efruxifermin (EFX) for non-alcoholic steatohepatitis (NASH) treatment.
Phase 2a data supports EFX’s potential in reducing rates of fibrosis
If approved, EFX could potential become a leading treatment alternative for NASH patients, including individuals with advanced-stage fibrosis.
Chief development officer Kitty Yale said, “Our confidence in EFX’s potential is based on Phase 2a data that showed substantial rates of fibrosis regression after only 16 weeks of treatment. We believe the larger Phase 2b HARMONY study, with a longer 24-week treatment period, will provide further evidence of EFX’s potential to reverse fibrosis as well as address the underlying metabolic disease drivers.”
The company’s Phase 2a BALANCED study results were published in Nature Medicine in 2021. The study evaluated biopsy-confirmed pre-cirrhotic NASH patients with results showing that 48% of the subjects who received EFX who had end-of-treatment biopsies attained some improvement without NASH worsening, and 48% attained NASH resolution and no fibrosis worsening.
At the end of the study, 68 percent of patients with F2/F3 fibrosis improved by at least one stage, and 50 percent improved by two stages. EFX was also found to reduce liver fat, indicators of fibrosis and liver injury, and body weight and enhance glycemic regulation and lipoprotein profile. In addition, EFX was said to be well tolerated by most people.
The study’s endpoint is fibrosis reduction without NASH progression at 24 weeks
The HARMONY trial is a randomized, multicenter, double-blind, placebo-controlled study in biopsy-confirmed NASH individuals with fibrosis stage 2 or 3. Patients were randomly assigned to receive either 50g or 28mg EFX subcutaneously once per week a placebo. T the primary objective is fibrosis reduction without progression of NASH after 24 weeks. Patients will be treated with EFX or placebo with a long-term follow-up period of at least to 96 weeks in order to generate long-term safety findings. Findings from the study are expected in the third quarter of 2022.
