SOUTH SAN FRANCISCO - Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company, has published a study indicating that its drug efruxifermin (EFX), when combined with GLP-1 receptor agonist therapy, shows promise in treating liver issues in patients with Type 2 diabetes.
The results, which appeared in Clinical Gastroenterology and Hepatology, come from a subset of the Phase 2b SYMMETRY study and suggest that EFX could be a significant treatment option for metabolic dysfunction-associated steatohepatitis (MASH), previously known as NASH.
The 12-week study evaluated the safety and tolerability of EFX in addition to a stable dose of GLP-1 receptor agonist (GLP-1RA) in patients with Type 2 diabetes and liver fibrosis. The results showed that the combination therapy was generally well-tolerated, with the most frequent adverse events being mild gastrointestinal issues. Importantly, the study reported a 65% reduction in liver fat and improvements in non-invasive markers of liver health for patients treated with the EFX and GLP-1RA combination, compared to a 10% reduction for those on GLP-1RA alone.
EFX is a Fc-FGF21 fusion protein designed to mimic the activity of the native hormone FGF21, which plays a role in regulating metabolism and reducing cellular stress. The treatment has the potential to address the multifaceted nature of MASH by reducing liver fat and inflammation, reversing fibrosis, and improving insulin sensitivity and lipid metabolism.
MASH is a severe form of liver disease affecting over 17 million Americans, characterized by fat accumulation in the liver, leading to inflammation and fibrosis, which can progress to more severe conditions. Currently, there are no approved treatments for MASH, which is the fastest-growing cause of liver transplants and liver cancer in the US and Europe.
Akero Therapeutics has ongoing Phase 3 clinical trials, the SYNCHRONY Histology and SYNCHRONY Real-World studies, to further evaluate EFX, including in patients already receiving GLP-1RA therapy. Another trial, the SYNCHRONY Outcomes study, is expected to start in the first half of 2024.
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