Akero Therapeutics, Inc. to Present Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis Due to NASH. The topline results will include histology and changes from baseline in non-invasive measures of fibrosis, glycemic control, and lipoproteins as well as safety and tolerability. About SYMMETRY: The Phase 2b SYMMETRY main study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with compensated cirrhosis (F4, Child-Pugh class A).

One hundred eighty-two patients have been randomized to receive once-weekly subcutaneous dosing of 28mg efruxifermin (EFX), 50mg EFX, or placebo. The primary endpoint for the trial is the proportion of subjects who achieve = 1 stage improvement in fibrosis with no worsening of NASH at week 36. Secondary endpoints include the proportion of patients who achieve NASH resolution with no worsening of fibrosis, the proportion of patients who achieve = 1 stage improvement in fibrosis and NASH resolution, change from baseline to week 36 in non-invasive markers of liver injury and fibrosis, glycemic control, lipoproteins, and body weight, as well as evaluation of safety and tolerability.

Patients will continue to receive EFX or placebo for up to 96 weeks. In June 2023, Akero reported topline data from an expansion cohort (N=31) of the Phase 2b SYMMETRY study known as Cohort D. The primary aim of the 12-week study was to assess safety and tolerability of EFX compared to placebo when added to an existing GLP-1 receptor agonist (GLP-1) in patients with Type 2 diabetes and F1-F3 liver fibrosis due to NASH. Results of the Cohort D study showed safety and tolerability endpoints were met.

The study also showed that adding EFX to GLP-1 therapy significantly improved non-invasive markers of NASH-related disease, including a 65% relative reduction in liver fat for the EFX-treated group compared with a 10% reduction for the placebo group treated only with GLP-1. Consequently, 88% of EFX-treated patients normalized their liver fat to 5% or less, compared with 10% for the placebo group. About Efruxifermin: Efruxifermin (EFX) is Akero?s lead product candidate for NASH, currently being evaluated in the ongoing Phase 2b HARMONY and SYMMETRY studies. EFX is designed 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 NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease ? the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

About Akero Therapeutics: Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including NASH, a disease without any approved therapies. Akero's lead product candidate, EFX, is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly subcutaneous dosing.

EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis, compensated).