Assembly Biosciences initiates Phase 2 trial of oral hepatitis D drug ABI‑6250

Assembly Biosciences announced the dosing of the first two participants in a Phase 2 study of ABI‑6250, a once‑daily oral entry inhibitor for chronic hepatitis D infection. The trial will involve roughly 80 patients and will assess safety, pharmacokinetics, pharmacodynamics and antiviral activity, with read‑out expected in the fourth quarter of 2027. Gilead Sciences holds an option to secure exclusive rights to the program for a $90 million fee if the Phase 2 results are positive.

The study could provide the first oral alternative to the currently approved injectable therapy, potentially expanding the market for hepatitis D treatments. If Gilead exercises its option, Assembly Biosciences would receive a $90 million upfront payment and may benefit from future milestone and royalty streams.

  • 1The Phase 2 study will include about 80 participants with chronic HDV infection.
  • 2Initial data from the study are expected in Q4 2027.
  • 3ABI‑6250 has a mean half‑life of roughly four days, supporting once‑daily oral dosing.
  • 4Gilead Sciences can obtain an exclusive license for ABI‑6250 by paying a $90 million opt‑in fee upon Phase 2 completion.

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