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FDA places clinical hold on Arrowhead's mid-stage study of lead product candidate in hepatitis B e antigen-positive patients

Published 11/08/2016, 09:14 PM
FDA places clinical hold on Arrowhead's mid-stage study of lead product candidate in hepatitis B e antigen-positive patients
ARWR
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  • Arrowhead Pharmaceuticals (NASDAQ:ARWR) announces that it has received verbal notice from the FDA that the agency has placed a clinical hold on its Phase 2 Heparc-2004 study assessing lead product candidate ARC-520 for the treatment of patients with chronic hepatitis B virus (HBV) infection who are also positive for e antigen (HBeAg). A clinical hold means that no additional patients can be recruited for the study and all dosing must stop in patients currently enrolled.
  • The action stems from questions related to a nonclinical toxicology study in non-human primates using the company's liver-targeted intravenously administered delivery vehicle called EX1. Specifically, there have been deaths at the highest dose, which is higher than that used in humans and higher than those used in previous animal toxicology studies. The specific cause of the animal deaths is being investigated.
  • The company says the FDA did not indicate that the hold was related to human data. It adds that EX1 has been administered over 800 times in more than 300 human subjects and patients with only three serious adverse events reported. About 6% of infusions have been associated with infusion reactions.
  • EX1 is also the delivery vehicle used in Arrowhead's ARC-521 and ARC-AAT programs.
  • ARC-520 is an RNAi therapeutic that intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogs act and is designed to silence the production of all HBV gene products.
  • Shares are holding steady after hours.

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