Arbutus Biopharma (NASDAQ: ABUS) has announced that the FDA has granted fast track designation for imdusiran for the treatment of chronic hepatitis B (cHBV).
Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens. It targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine delivery technology enabling subcutaneous delivery.
In a statement, Lindsay Androski, president and CEO of Arbutus, commented, “We are excited about the potential of imdusiran, which in trials has achieved functional cure for 10 chronic hepatitis B patients to date and allowed many others to live medication-free, to address significant unmet medical need. The FDA grant of fast track designation validates imdusiran as an important drug candidate, and we look forward to working collaboratively and closely with the FDA during the remaining stages of the development process.”
