Akero Therapeutics, a clinical-stage company focused on developing treatments for metabolic diseases, has announced the dosing of the first patient in the Phase 3 SYNCHRONY Outcomes study. This trial evaluates efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH). The advancement marks a significant step in Akero's efforts to address the unmet medical needs of patients with MASH.
SYNCHRONY Phase 3 Program
The SYNCHRONY program consists of three randomized, placebo-controlled trials designed to assess the safety and efficacy of EFX in patients with both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4). These trials build upon data from two Phase 2b studies, which collectively treated 300 patients for up to 96 weeks.
- SYNCHRONY Outcomes (F4, compensated): This study is evaluating EFX in patients with compensated cirrhosis (F4) due to MASH. Patients receive weekly injections of either EFX 50mg or placebo. The primary histology endpoint, for Cohort 1, is the proportion of patients experiencing ≥ 1-stage improvement in fibrosis and no worsening of steatohepatitis after 96 weeks of treatment. The primary outcomes endpoint is measured as the time from randomization to first occurrence of any of the protocol-specified clinical events across all patients enrolled in Cohort 1 and Cohort 2.
- SYNCHRONY Histology (F2-F3): This study is evaluating EFX in patients with pre-cirrhotic MASH (F2-F3). Patients receive weekly injections of EFX 28mg, EFX 50mg, or placebo. The primary histology endpoint (Cohort 1 only) is the proportion of patients experiencing ≥ 1-stage fibrosis improvement AND resolution of MASH after 52 weeks of treatment. Results for the 52-week primary histology endpoint are expected in the first half of 2027.
- SYNCHRONY Real-World (F1-F4): This study is enrolling patients with MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) to receive weekly injections of EFX 50mg or placebo. The primary endpoint of safety and tolerability will be assessed after 52 weeks of treatment. Results from the SYNCHRONY Real-World study are expected in 2026.
Phase 2b SYMMETRY Study
The ongoing Phase 2b SYMMETRY study is evaluating the efficacy and safety of EFX in patients with compensated cirrhosis (F4) due to MASH, who were treated with EFX 28mg, EFX 50mg or placebo for up to 96 weeks. Week 96 results are on track to be reported in February 2025.
Financial Update
As of September 30, 2024, Akero's cash, cash equivalents, and marketable securities totaled $787.1 million. The company believes these funds will be sufficient to support the SYNCHRONY Histology and Real-World studies through the readout of their primary endpoints, as well as Akero's current operating plan into the second half of 2027.
About Efruxifermin (EFX)
Efruxifermin (EFX) is Akero's lead product candidate for MASH, engineered to mimic the biological activity of native FGF21. EFX aims to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity, and improve lipid metabolism. It is designed for convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.
MASH Disease Burden
MASH is a severe form of MASLD, affecting over 17 million Americans. It is characterized by excessive liver fat accumulation, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer, and death. MASH is the fastest-growing cause of liver transplants and liver cancer in the US and Europe.
