Assembly Biosciences Starts Phase 2 HDV Trial
The investigational oral entry inhibitor aims to replace daily injections for patients with chronic hepatitis delta.
Updated on Oct. 29, 2026 in Biotech
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Assembly Biosciences has begun a Phase 2 clinical trial for ABI-6250, an investigational oral small-molecule entry inhibitor for chronic hepatitis delta virus (HDV) infection. The study aims to evaluate the drug's safety and efficacy in approximately 80 participants.
Why it matters
Current treatment for chronic HDV is limited to daily peptide inhibitor injections, making the development of a once-daily oral option a potential shift in patient care. The drug functions by inhibiting NTCP, a transport protein that blocks the virus from entering liver cells.
ABI-6250 demonstrates a mean half-life of approximately four days, potentially supporting a once-daily oral dosing regimen. The trial will compare two different dose levels against a delayed-treatment control group.
The players
Assembly Biosciences
A biotech company focused on developing oral therapies for chronic viral infections including hepatitis.
Gilead Sciences
A pharmaceutical developer that holds an option for an exclusive $90 million license for ABI-6250.
The details
The drug works as an entry inhibitor that targets NTCP, or sodium-taurocholate cotransporting polypeptide, a receptor on the surface of hepatocytes (liver cells) that the hepatitis delta virus uses to enter and infect the cell. By blocking this pathway, the oral small-molecule prevents the virus from gaining a foothold in the liver. This trial is assessing whether the drug can provide a durable therapeutic effect when taken once daily, contrasting with the current injectable peptide standard.
Timeline
October 2023: Assembly Biosciences and Gilead Sciences formed a 12-year collaboration agreement.
October 29, 2026: The first two participants received their initial dose of ABI-6250.
Q4 2027: Initial study data is expected to be released.
The Tech Race
This trial follows the 12-year collaboration agreement established between Assembly Biosciences and Gilead Sciences in 2023. It represents a move to replace current injectable peptide inhibitors with more convenient oral delivery systems.
For patients with chronic HDV, this trial tests a potential transition from daily injections to a once-daily oral medication. No current commercial availability exists, and the drug is currently restricted to clinical trial participants.
The takeaway
The study marks a shift toward oral delivery methods for chronic liver viral entry inhibition. Watch for the initial data release in the fourth quarter of 2027 to see if the clinical results validate the drug's mean half-life and efficacy profile.
What happens next
Following the main cohort analysis, an expansion group of 20 to 30 additional participants will be selected for further study.
Further reading
Explore more ongoing research at the Biotech section.
More information
View the Phase 2 clinical trial information for specific study design details.
Source note: This article includes information reported by The Manila times.
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