- 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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