Assembly Bioscience announced the initiation of two randomized control phase 2a trials for ABI-H0731, the company’s lead hepatitis B core inhibitor, according to a press release.
ABI-H0731 previously demonstrated potent antiviral activity in a phase 1b trial, the results of which were presented at the International Liver Congress 2018 in Paris.
“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,” Uri Lopatin, MD, chief medical officer of Assembly Biosciences, said in the release. “Such a result would support that clinical cure of chronic HBV may be possible with a finite course of direct acting combination therapy.”
The first phase 2a trial will comprise approximately 45 patients positive for HBV e-antigen whose viral load has already been suppressed by nucleos(t)ide therapy. Patients will receive ABI-H0731 or placebo for 6 months. Researchers will follow the patients for HBeAg and HBV surface antigen levels.
The second trial will comprise approximately 24 patients without previous nucleos(t)ide therapy. Similar to the first trial, patients will receive ABI-H0731 or placebo for 6 weeks and have their HBeAg and HBsAg levels tested.
Assembly Bioscience expects results in the first half of 2019.