Assembly reports Phase Ib data for HBV candidate

Assembly Biosciences Inc. (NASDAQ:ASMB) reported data from the Phase Ib ABI-H0731-101b trial in treatment-naïve patients with chronic HBV infection showing that ABI-H0731 was generally well tolerated with no serious adverse events or dose-limiting toxicities (DLTs) reported. There was one case of grade 3 rash at the 400 mg dose that the company said resolved rapidly without intervention other than treatment discontinuation. ABI-H0731 is an HBV core protein allosteric modifier.

The trial enrolled hepatitis B e antigen (HBeAg)-positive and -negative patients with chronic HBV infection to receive placebo or once-daily 100, 200, 300 or 400 mg doses of oral ABI-H0731 for 28 days. ABI-H0731 reduced mean HBV DNA levels from baseline by 1.7 log₁₀ IU/mL at the 100 mg dose (n=10), 2.1 log₁₀ IU/mL at the 200 mg dose (n=10) and ≥2.8 log₁₀ IU/mL at the 300 mg dose (n=9). Dosing has not yet been completed in the two higher dose cohorts...