Akero Therapeutics, Inc. announced publication of results in Clinical Gastroenterology and Hepatology from an expansion cohort (Cohort D, N=31) of the Phase 2b SYMMETRY study. The publication, available online, reports results of the 12-week study to assess safety and tolerability ofefruxifermin (EFX) compared to placebo when added to a stable dose of GLP-1 receptor agonist (GLP-1RA) in patients with Type 2 diabetes (T2D) and F1-F3 liver fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Tolerability of EFX on top of GLP-1RA (N=21 patients) was generally comparable to GLP-1RA alone (placebo, N=10).

The most frequent adverse events for EFX-treated patients were grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite). EFX appears to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipids. This holistic approach offers the potential to address the complex, multi-system disease state of MASH, including improvements in steatohepatitis (F2-F3 fibrosis) and the SYNCHRONY Real-World study in patients with MASH or MASLD.

A third clinical trial, the SYNCHRONY Outcomes study in patients with cirrhosis due to MASH, is expected to be initiated in the first half of 2024. The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with cirrhotic MASH. Akero is headquartered in South Francisco.

Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set out in or implied by such forward-looking statements. R risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero's ability to fund operations; as well as those risks and uncertainties set out in the United States and foreign country; Akero's ability to Fund operations; as well as those risk and uncertainties set out in the U.S.