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Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced Phase 1b clinical data for its next-generation investigational capsid assembly modulator (CAM) ABI-4334 featured in a late-breaking poster presentation at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting®. The conference is taking place November 7-11, 2025, in Washington, D.C.
The late-breaking poster presentation titled "Safety, pharmacokinetics and antiviral activity of the next-generation hepatitis B capsid assembly modulator ABI-4334 in patients with HBeAg-negative chronic hepatitis B infection not suppressed on nucleoside analogues: results from a randomized, blinded, Phase 1b study" highlights data in individuals with chronic hepatitis B infection treated with ABI-4334. This poster is the first scientific presentation of the complete Phase 1b data announced earlier this year by Assembly Bio.
Two cohorts of predominantly HBeAg-negative subjects were enrolled, evaluating 150 mg and 400 mg oral doses of ABI-4334 given once-daily over 28 days. ABI-4334 was well tolerated at both doses evaluated. Multi-log declines in hepatitis B virus (HBV) DNA and pregenomic RNA (pgRNA) were observed for both doses, consistent with the increased in vitro potency of ABI-4334 compared to first-generation CAMs. These declines in HBV DNA and pgRNA are supportive of full engagement of the first CAM mechanism of action, suppression of viral replication. Exposures multiple folds above levels anticipated to be required for inhibition of cccDNA formation, the second CAM mechanism of action, were also observed at both dose levels. As expected in predominantly HBeAg-negative patients with a short dosing interval, reductions in HBsAg were not observed.
Posted In: ASMB
