25 July 2018 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H0731 for the treatment of patients with chronic hepatitis B infection.
ABI-H0731 is Assembly’s lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients.
Assembly recently initiated two multi-center, randomized, placebo controlled Phase 2a trials of ABI-H0731, which are actively recruiting and dosing subjects at multiple locations in the U.S. and globally.