Biotechnology company Akero Therapeutics Inc (Nasdaq:AKRO) revealed on Tuesday that it has dosed the first patient with NASH under its Phase 2a clinical study of AKR-001.

NASH is a leading cause of liver failure around the world, driven by the growing global epidemic of obesity. NASH is a severe form of non-alcoholic fatty liver disease (NAFLD) characterised by liver cell (hepatocyte) damage, liver inflammation and fibrosis that can progress to cirrhosis, liver failure, cancer and death.

According to the company, the AKR-001 is an engineered human Fc-FGF21 fusion protein designed to harness the inherent benefits of an endogenous hormone called FGF21, which has the potential to reduce liver fat, mitigate inflammation and reverse fibrosis in NASH patients.

This multicentre, randomised, double-blind, placebo-controlled, dose-ranging Phase 2a BALANCED study in biopsy-confirmed patients with NASH has enrolled up to 80 patients. The patients are expected to be randomized to receive weekly subcutaneous dosing of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20. AKR-001 is uniquely designed to deliver sustained signaling through FGF21's receptors with once-weekly subcutaneous dosing.

The company added that the primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF) Week 12.