Akero Therapeutics to Report Results of Phase 2b SYMMETRY Study in October 2023

SOUTH SAN FRANCISCO, Calif., Aug. 28, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that all samples and data required for a readout of topline results from the Phase 2b SYMMETRY study have been collected, which supports the expected timing of readout in October of this year. The topline week 36 results from the study, evaluating treatment of patients with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH), will include histology and changes from baseline in non-invasive measures of fibrosis, glycemic control, and lipoproteins as well as safety and tolerability.

Akero plans to hold an investor webcast detailing the findings.

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 measures of fibrosis, glycemic control, lipoproteins, and body weight, as well as evaluation of safety and tolerability. To provide longer-term safety data, 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.