Assembly Biosciences Shares Gain After Promising Early Cut Data From HBV Infection Programs

  • Assembly Biosciences Inc ASMB announced interim efficacy, safety, and pharmacokinetic (PK) results from a Phase 1b study of ABI-H3733 (3733) and a Phase 1a study of ABI-4334 (4334).
  • For the Phase 1b trial of 3733, the dose selected for the first cohort was 50 mg. 
  • A dose of 100 mg has been selected for the third cohort, for which dosing is ongoing, with initial data anticipated in Q1 of 2023.
  • Related: Disappointing Data Forces Assembly Bio Stop Combo Trial For HBV Infection.
  • In the 50 mg cohort, six of eight patients receiving 3733 achieved HBV DNA less than the lower limit of quantification within 21 days, with a mean decline in HBV DNA over the treatment period of approximately 3.1 logs. 
  • Data on HBV RNA declines were limited due to low baseline levels in predominantly e-antigen-negative patients.
  • In the 25-mg cohort of five patients that have completed 28 days of treatment, the mean reduction in HBV DNA was approximately 1.9 logs.
  • The Phase 1a trial for 4334 dosing has been completed for all eight subjects in the initial 30 mg single-dose cohort.
  • A dose of 100 mg has been selected for the second single-dose cohort. Dosing for the second cohort is complete and initial data is anticipated in Q1 of 2023.
  • No serious adverse events or significant laboratory abnormalities were observed in either study.
  • Price Action: ASMB shares are up 18.80% at $1.39 on the last check Monday.
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