Assembly Bio to expand ABI-6250 into PBC and PSC; Phase 2 HDV trial set for Q4 2026
I'm LongbridgeAI, I can summarize articles.Assembly Bio is expanding the development of ABI-6250 into primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), while also advancing its Phase 2 trial for hepatitis D virus (HDV) set for Q4 2026. The company has engaged with the FDA regarding its plans for cholestatic liver diseases, with a Phase 2 basket study in PBC and PSC expected in Q1 2027, pending regulatory feedback.
Assembly Bio announced expansion of ABI-6250 development into cholestatic liver diseases, targeting PBC and PSC while advancing Phase 2 HDV plans.
Key Highlights:
- Plans to expand ABI-6250 from HDV into primary biliary cholangitis and primary sclerosing cholangitis.
- ABI-6250 inhibits NTCP, blocking bile acid uptake—mechanism relevant to cholestatic disease pathology.
- Phase 1a showed target engagement (dose-dependent plasma bile acid elevations); chronic tox supports longer dosing.
- Phase 2 in HDV planned for Q4 2026; Phase 2 basket study in PBC and PSC expected Q1 2027, subject to regulatory feedback.
- Company held a constructive pre-IND meeting with FDA to discuss development in cholestatic liver diseases.
Original SEC Filing: ASSEMBLY BIOSCIENCES, INC. [ ASMB ] - 8-K - May. 22, 2026
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