Assembly Biosciences presented Phase 1b clinical data for its next‑generation capsid assembly modulator ABI‑4334 at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting on November 7, 2025. The poster highlighted safety and tolerability in patients with HBeAg‑negative chronic hepatitis B who received once‑daily doses of 150 mg or 400 mg for 28 days.
The study demonstrated multi‑log reductions in hepatitis B virus DNA and pregenomic RNA at both dose levels, confirming the drug’s potent antiviral activity. The dual mechanism of action—targeting viral replication and cccDNA formation—suggests that ABI‑4334 could play a key role in combination regimens aimed at achieving a functional cure for chronic hepatitis B.
Assembly Biosciences is partnered with Gilead Sciences under a 12‑year collaboration that gives Gilead an option to license ABI‑4334 after reviewing the data package. The option represents a significant validation of the pipeline and could provide both additional funding and regulatory support if Gilead chooses to exercise the license.
The company remains a clinical‑stage biopharma with no revenue from approved products and negative operating margins driven by heavy R&D investment. Positive Phase 1b data, however, strengthen the company’s position for future funding rounds and enhance investor confidence in the pipeline’s potential to address an unmet medical need.
The presentation marks a critical step toward potential regulatory submissions and positions Assembly Biosciences to advance ABI‑4334 toward a functional cure, while also reinforcing the strategic partnership with Gilead and the company’s broader pipeline momentum.
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