Clinical Trials

Date: 2016-01-07

Type of information: Treatment of the first patient

phase: 2b

Announcement: treatment of the first patient

Company: Arrowhead Research Corporation (USA - CA)

Product: ARC-520

Action mechanism:

RNAi/siRNA. ARC-520 is a small interfering RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of the reverse transcription process where current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC-520 specifically to determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without seroconversion.

Disease: hepatitis B

Therapeutic area: Infectious diseases

Country: Australia, Bulgaria, China, Republic of Korea, Republic of Moldova, New Zealand, Taiwan, Thailand

Trial details:

The MONARCH study, also called Heparc-2008, is a multicenter, open-label study to evaluate ARC-520 administered alone and in combination with other therapeutics in patients with chronic hepatitis B virus infection. The primary outcome measure is the percentage of patients achieving a 1-log reduction in hepatitis B surface antigen (HBsAg) compared to baseline. Secondary outcome measures include the percentage of patients achieving HBsAg loss and time to HBsAg loss based on qualitative assay, percentage of patients achieving anti-HBs seroconversion and time to anti-HBs seroconversion (antibody to HBsAg), percentage of patients achieving a 1-log reduction in HBsAg and achieving a HBsAg level less than 100 IU/L, as well as other outcome measures. Patients with chronic Hepatitis B Virus (HBV) infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon alpha 2a (PEG IFN) therapy, and be evaluated for safety and efficacy. (NCT02577029)

Latest news:

• On January 7, 2016, Arrowhead Research Corporation announced that the company has dosed the first patient in the Phase 2b MONARCH combination study of ARC-520, it's RNAi-based drug for the treatment of chronic hepatitis B virus (HBV) infection. The clinical trial is currently enrolling patients at multiple centers in Australia and New Zealand. MONARCH is intended to identify one or more combinations of ARC-520 and other therapeutic agents that can potentially lead to a functional cure of chronic HBV. The initial six cohorts are each planned to consist of up to twelve treatment naïve patients. Patients in cohort 1 will receive ARC-520 as monotherapy once every 4 weeks for 48 weeks (13 doses). Patients in cohorts 2-6 will be stratified by e-antigen status and HBV genotype. They will receive the same regimen of ARC-520 for 48 weeks in combination with daily entecavir for 60 weeks and pegylated interferon alpha 2a (PEG IFN) for 48 weeks. MONARCH is designed to allow for new cohorts to be added that test additional dosing regimens and different combinations as new agents become available for study.