Potential Hepatitis B Therapy Reduces Virus Surface Antigen in Clinical Trial

In its multiple-ascending dose trial, ARO-HBV demonstrated reductions in circulating hepatitis B virus surface antigen.

A potentially curative therapy for hepatitis B virus (HBV) showed positive results in an early-phase clinical trial, according to recent data.

ARO-HBV is a subcutaneously administered RNA interference (RNAi) therapy being developed for the treatment of HBV infection, according to a press release.

In a phase 1/2 study called AROHBV1001, the drug was evaluated in patients with chronic HBV who received 3 monthly doses of ARO-HBV. Dosing in the single-ascending doses (SAD) included 5 cohorts at dose levels of 35, 100, 200, 300, and 400 mg. Dosing in the ongoing multiple-ascending doses (MAD) includes 10 cohorts receiving 3 doses either weekly, bi-weekly, or monthly, and includes dose levels of 100, 200, 300, and 400 mg.

According to the data from the 8 patients in the lowest 2 dose cohorts, 3 monthly doses of ARO-BV led to a maximum reduction in circulating HBsAG of 4.0 log10 (99.99%), with mean reductions of approximately 2.0 log10 (99%) on day 85 in the 100-mg cohort and 1.4 (96%) log10 on day 71 in the 200-mg cohort. Minimum HBsAg reduction in all patients from the 100-mg cohort and 200-mg cohort was 1.2 log10 (93%).

All 8 patients achieved greater than 1.0 log10 reductions in circulating HBsAg.

Additionally, activity was demonstrated in all patient types and appeared to be generally well-tolerated, with mild and self-limiting injection site adverse events being the most common adverse effects, according to the study. Other most commonly reported events included symptoms consistent of upper respiratory tract infection and headache.

“These initial results from the first 2 multiple-ascending dose cohorts of the AROHBV1001 clinical study are encouraging and indicate that ARO-HBV is highly active,” Bruce Given, MD, Arrowhead’s chief operating officer and head of research and development, said in a press release.

The data will be presented at the 18th World Gastroenterologists Summit in Auckland, New Zealand.


Arrowhead Presents New ARO-HBV Clinical Data Demonstrating HBsAg Reductions at World Gastroenterologists Summit [news release]. Arrowhead Pharmaceuticals’ website. http://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-presents-new-aro-hbv-clinical-data-demonstrating-hbsag. Accessed September 11, 2018.