Benzinga | Jun 1, 2021 08:10AM EDT

Akero Therapeutics To Present Efruxifermin Results Showing Histologic Improvement In EFX-Treated F4 Cirrhotic Patients As Late-Breaker Oral Presentation At The 2021 International Liver Congress

Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that it will present results from the Cohort C extension of its Phase 2a BALANCED study, which found positive histological improvements in F4 NASH patients with compensated cirrhosis after 16 weeks of treatment with efruxifermin (EFX), at the 2021 International Liver Congress hosted by the European Association for the Study of the Liver (EASL) on June 26 at 1:00 p.m., Central European Time. Akero will also report data from the BALANCED main study in F2/F3 NASH patients in two other presentations at EASL and in two presentations at the 81st Meeting of the American Diabetes Association (ADA) taking place June 25-29.



"We believe the consistency, magnitude and reproducibility of treatment effect sets efruxifermin apart in the NASH arena," said Kitty Yale, chief development officer of Akero. "The data we will present in June at EASL and ADA show consistently strong results for EFX in improvinghistology, liver health, glycemic control, and lipoprotein profile in patients with F2/F3 NASH, and unprecedented and promising results in patients with F4 compensated cirrhosis. We believe we will continue to see meaningful histologic improvements in our ongoing Phase 2b HARMONY study in NASH patients with F2/F3 fibrosis and the Phase 2b SYMMETRY study in NASH patients with F4 compensated cirrhosis, which we plan to initiate in the second half of this year."

Presentations at the EASL International Liver Congress, June 23-26:

* EASL Abstract No. 2800 (Late breaker oral presentation), "Efruxifermin (EFX) improved markers of fibrosis, liver injury and metabolism in F4 NASH patients with compensated cirrhosis," presented by Stephen Harrison, M.D.

* EASL Abstract No. 1314: "The role of reduction in liver fat content (MRI-PDFF) and ALT in predicting treatment response in NASH: A secondary analysis of the randomized, controlled BALANCED trial," presented by Rohit Loomba, M.D.

* EASL Abstract No. 1762: "Correlation between changes in liver fat content and improvements in serum markers of liver injury, fibrosis, metabolism, and in histologic parameters following treatment with efruxifermin," presented by Stephen Harrison, M.D.

Presentations at the 81st ADA Scientific Sessions meeting, June 25-29:

* ADA Abstract 116-LB: "Efruxifermin is associated with improved glucose metabolism in patients with NASH and type 2 diabetes," presented by Juan P. Frias, M.D.

* ADA Abstract 119-LB: "Increased adiponectin following efruxifermin treatment is associated with improvements in dyslipidemia, glucose metabolism, and liver health in a 16-week, randomized, placebo-controlled NASH trial," presented by Juan P. Frias, M.D.

"Patients with type 2 diabetes, many of whom also have NASH with fibrosis, have a significant need for novel therapies that can treat NASH while improving diabetes control and reducing the high risk of cardiovascular disease," said Dr. Juan Frias, Medical Director and Principal Investigator of the National Research Institute. "EFX appears to have the potential to meet this high unmet medical need by reversing liver injury and fibrosis, restoring a healthy lipoprotein profile while enhancing insulin sensitivity, and improving glycemic control even in patients on existing antidiabetic medications."