Assembly Bio Stock Tumbles On Discontinuation Of Hepatitis B Trial

  • Assembly Biosciences Inc ASMB has decided to discontinue the development of ABI-H2158 (2158) following the observation of elevated alanine transaminase (ALT) levels consistent with drug-induced hepatotoxicity (liver damage) in the Phase 2 trial.
  • The FDA noted that 2158 would also be placed on clinical hold.
  • The Phase 2 study enrolled 88 treatment-naïve patients with HCV-positive or HCV-negative chronic hepatitis B infection without cirrhosis.
  • In the study, two patients receiving 2158 experienced life-threatening elevations in ALT, leading to drug discontinuation. 
  • Two additional patients developed severe 3 ALT elevations. 
  • Related content: Benzinga's Full FDA Calendar.
  • Also Read: Assembly Biosciences Foregoes Vebicorvir Registration Studies For Chronic Suppressive Therapy.
  • Price Action: ASMB shares are down 21% at $3.08 during the premarket session on the last check Thursday.
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