Akero Therapeutics, a clinical-stage company, is making strides in developing treatments for metabolic dysfunction-associated steatohepatitis (MASH) with its lead product candidate, efruxifermin (EFX). The company reported its third-quarter 2024 financial results and provided a business update, highlighting the progress of its Phase 3 SYNCHRONY program. A significant milestone was achieved with the first patient dosed in the SYNCHRONY Outcomes study, which focuses on patients with compensated cirrhosis (F4) due to MASH.
SYNCHRONY Program Updates
The Phase 3 SYNCHRONY program consists of three ongoing, randomized, placebo-controlled trials designed to evaluate the safety and tolerability of EFX. These trials aim to support marketing applications for both pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4). The program builds upon data from two Phase 2b studies, which collectively treated 300 patients for up to 96 weeks.
- SYNCHRONY Outcomes: 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, assessed in Cohort 1, is the proportion of patients experiencing ≥ 1-stage improvement in fibrosis without worsening of steatohepatitis after 96 weeks. The primary outcomes endpoint measures the time to the first occurrence of protocol-specified clinical events across all patients.
- SYNCHRONY Histology: This trial is focused on patients with pre-cirrhotic MASH, fibrosis stage 2 or 3 (F2-F3). Patients are receiving 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. Results for this endpoint are expected in the first half of 2027.
- SYNCHRONY Real-World: 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 is safety and tolerability, assessed after 52 weeks of treatment. Results are expected in 2026.
SYMMETRY Phase 2b Study
The ongoing Phase 2b SYMMETRY study is evaluating the efficacy and safety of EFX in patients with compensated cirrhosis (F4) due to MASH, treated with EFX 28mg, EFX 50mg, or placebo for up to 96 weeks. Week 96 results are anticipated in February 2025.
Financial Position
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 Phase 3 SYNCHRONY Histology and Real-World studies through the readout of their primary endpoints and Akero's current operating plan into the second half of 2027. Research and development expenses for the third quarter of 2024 were $72.2 million, compared to $38.6 million for the same period in 2023. Total operating expenses for the quarter were $81.7 million, compared to $46.6 million in 2023.
About Efruxifermin
Efruxifermin (EFX) is Akero's lead product candidate, a differentiated Fc-FGF21 fusion protein 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.
MASH Disease Context
MASH is a severe form of MASLD, affecting over 17 million Americans. It involves excessive fat accumulation in the liver, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer, and death. MASH is a rapidly growing cause of liver transplants and liver cancer in the US and Europe.
