Assembly Biosciences Expands ABI-6250 Development to Target Cholestatic Liver Diseases
Assembly Biosciences Announces Expansion of ABI-6250 Clinical Development Into Cholestatic Liver Diseases
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Assembly Biosciences, based in South San Francisco, California, is expanding its clinical development of ABI-6250, an oral entry inhibitor for chronic hepatitis delta virus (HDV), to include primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). The Phase 2 study is set to begin in Q1 2027, addressing significant unmet medical needs in these cholestatic liver diseases.
- 01ABI-6250 targets the sodium taurocholate co-transporting polypeptide (NTCP), crucial for both HDV entry and bile acid transport.
- 02The Phase 2 clinical study in HDV is scheduled for Q4 2026, while the study for PBC and PSC will follow in Q1 2027.
- 03Current therapies for PBC are inadequate for a significant percentage of patients, and no approved treatments exist for PSC.
- 04Preclinical data and Phase 1a results support the potential of ABI-6250 in cholestatic liver diseases.
- 05The company recently held a pre-IND meeting with the U.S. Food and Drug Administration to discuss the development of ABI-6250.
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Assembly Biosciences, Inc. (NASDAQ: ASMB) has announced an expansion of its clinical development program for ABI-6250, an investigational oral entry inhibitor for chronic hepatitis delta virus (HDV), to include primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), both cholestatic liver diseases. The Phase 2 study for these conditions is anticipated to begin in the first quarter of 2027, building on the completed Phase 1a study and ongoing HDV development. ABI-6250 targets the sodium taurocholate co-transporting polypeptide (NTCP), which is vital for HDV entry and bile acid transport into liver cells. This makes it a promising candidate for addressing key drivers of disease pathology in cholestatic liver diseases, where bile acid accumulation leads to liver inflammation and injury. Notably, while there are multiple therapies for PBC, many patients do not respond adequately, and there are currently no approved treatments for PSC. The company plans to initiate a Phase 2 clinical study for HDV in the fourth quarter of 2026 and has received constructive feedback from the U.S. Food and Drug Administration regarding its plans for ABI-6250.
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The expansion of ABI-6250 into cholestatic liver diseases could provide new treatment options for patients suffering from PBC and PSC, addressing significant unmet medical needs.
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