Assembly Bio reports Phase 1a safety and target-engagement results for ABI-6250

Assembly Biosciences said its Phase 1a trial of oral NTCP inhibitor ABI-6250 in healthy participants found the drug was tolerated, with no serious adverse events, and produced reversible bile-acid increases consistent with target engagement. The company will present the findings in two posters at the AASLD Liver Meeting in Denver. Assembly Bio said it plans to begin Phase 2 work in chronic HDV and cholestatic liver diseases in subsequent periods.

The Phase 1a findings provide safety and pharmacodynamic support for Assembly Bio's stated plan to advance ABI-6250 into Phase 2 studies. The reported study was in healthy participants, so patient efficacy data were not provided.

  • 1Assembly Biosciences said ABI-6250 had no serious adverse events in its randomized, blinded Phase 1a study of healthy participants.
  • 2The company reported dose-related and reversible increases in total and conjugated bile acids, which it said were consistent with NTCP engagement.
  • 3Assembly Biosciences plans to start a chronic HDV Phase 2 study in the fourth quarter of 2026.
  • 4The company plans a Phase 2 study in cholestatic liver diseases in the first quarter of 2027.
  • 5Assembly Biosciences will show two ABI-6250 posters at the AASLD meeting in Denver from November 5-9, 2026.
  • The materials do not report patient efficacy results for ABI-6250, as the Phase 1a study involved healthy participants.

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