Assembly Biosciences, Inc. (NASDAQ: ASMB), today announced the initiation of two multi-center, randomized, placebo controlled Phase 2a trials of ABI-H0731 for the treatment of patients with chronic HBV infection. ABI-H0731 is Assembly’s lead HBV core inhibitor shown to exhibit potent antiviral activity in a Phase 1b trial, the results of which were presented in April at the European Association for the Study of the Liver (EASL) meeting in Paris.
“We are excited to initiate these next clinical studies, which will evaluate ABI-H0731 in combination with standard nucleos(t)ide therapy in patients with chronic HBV infection,” said Uri Lopatin, MD, Chief Medical Officer of Assembly Biosciences. “These studies will provide data on the potential of ABI-H0731 to increase cure rates by suppressing viral replication to a greater degree than is currently achieved with standard nucleos(t)ide therapy alone. Such a result would support that clinical cure of chronic HBV may be possible with a finite course of direct acting combination therapy.”
“Even with indefinite treatment with the currently available nucleoside and nucleotide inhibitors, we are not able to fully suppress viral replication, which will be necessary for patients to achieve a cure for chronic HBV,” said Douglas T. Dieterich, M.D., Director, Institute of Liver Medicine, Professor of Medicine at Mount Sinai, New York, and an investigator on both trials. “Core inhibitors target different parts of the HBV life cycle than the current therapies, and may result in both greater viral suppression and increased loss of cccDNA, which is central to HBV persistence. Combining these new mechanisms of action with existing direct acting antivirals looks promising. I look forward to exploring this further in the trials and seeing the results.”