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.