Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today announced that results from Cohort C of its Phase 2a BALANCED trial in non-alcoholic steatohepatitis (NASH) have been published in JHEP Reports. Study results showed that efruxifermin (EFX) was well-tolerated in this cohort of patients with compensated cirrhosis, similar to results observed in the BALANCED main study of patients with pre-cirrhotic NASH.
The paper, available online, provides data on the safety, tolerability, and efficacy of once-weekly subcutaneous injections of 50 mg EFX compared to placebo in Cohort C in adult patients with cirrhotic NASH (compensated stage 4 fibrosis, Child-Pugh Class A), who typically have a worse prognosis and higher mortality than those with an earlier stage of fibrosis. Over 16 weeks of treatment, liver stiffness and serum markers of fibrosis significantly decreased compared to baseline. EFX treatment also improved whole-body metabolism, with significant improvement in lipoprotein profile and decrease in HbA1c.
“These encouraging results reaffirm our confidence in EFX as a potential foundational monotherapy for patients with NASH, including those with advanced-stage fibrosis,” said Kitty Yale, chief development officer of Akero. “We are looking forward to sharing data from our larger Phase 2b HARMONY study in September 2022 and are hopeful they will provide further evidence of EFX’s potential to reverse fibrosis, as well as address the underlying metabolic drivers of the disease. We also look forward to reporting the results of our Phase 2b SYMMETRY study in patients with cirrhotic NASH, which remains on track to be reported in the second half of 2023.”
NASH is a progressive liver disease that can lead to liver cancer, liver failure, and increased risk or cardiac events. There are no approved therapies. EFX is a long-acting FGF21 analog that mimics native FGF21’s biological activities in vitro.