Akero Announces Dosing of First Patient in NASH Study

Akero Therapeutics announced the dosing of the first patient in its Phase 2a clinical study of AKR-001, a novel FGF21 analog, for the treatment of NASH (the BALANCED study).

"Akero's AKR-001 clinical program is progressing as planned and we remain on track to report study results in the first half of 2020," said Kitty Yale, Chief Development Officer, Akero Therapeutics. "We are excited about the potential benefits that AKR-001 may offer to patients with NASH, a serious metabolic disease for which there are no FDA-approved treatment options."

The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed patients with NASH. Up to 80 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. 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.

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. AKR-001 is uniquely designed to deliver sustained signaling through FGF21's receptors with once-weekly subcutaneous dosing.

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) characterized by liver cell (hepatocyte) damage, liver inflammation, and fibrosis that can progress to cirrhosis, liver failure, cancer and death.

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