other material
confidence high
sentiment positive
materiality 0.80
Assembly Biosciences reports interim Phase 1b data for ABI-4334 with 2.9 log10 IU/mL mean HBV DNA reduction
ASSEMBLY BIOSCIENCES, INC.
- ABI-4334 was well-tolerated with favorable safety profile; no serious adverse events or discontinuations in either cohort.
- In 150 mg dose cohort, mean HBV DNA declined 2.9 log10 IU/mL and mean HBV RNA declined 2.5 log10 U/mL over 28 days.
- Half-life supports once-daily oral dosing; Cmin multiples above EC50 for antiviral activity and cccDNA inhibition.
- Enrollment ongoing for 400 mg cohort, expected final cohort; data anticipated in first half of 2025.
- Gilead Sciences has opt-in rights to further develop and commercialize ABI-4334 after completion of Phase 1b study.