Aa
Arrowhead Begins Dosing the Phase 2b MONARCH Combination Study of ARC-520
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, 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.
“We recently reported clinical data from our Phase 2a study at AASLD showing that a single dose of ARC-520 can achieve a reduction of up to 99% in hepatitis B surface antigen, and nonclinical data at HepDART showing that multiple doses of ARC-520 were associated with immune reactivation in 7 of 9 chimpanzees studied. These data make us very eager to see results as they emerge from MONARCH and our other multiple dose studies,” said Christopher Anzalone, Ph.D., Arrowhead president and CEO. “The goal of MONARCH is to identify one or more combinations of ARC-520 and other agents that enable functional cures in patients. If we can achieve this, it would represent a big leap forward in the field and provide hope for the more than 350 million people worldwide chronically infected with the hepatitis B virus.”
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.
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.
http://www.businesswire.com/news/home/20160107005349/en/Arrowhead-Begins-Dosing-Phase-2b-MONARCH-Combination
“We recently reported clinical data from our Phase 2a study at AASLD showing that a single dose of ARC-520 can achieve a reduction of up to 99% in hepatitis B surface antigen, and nonclinical data at HepDART showing that multiple doses of ARC-520 were associated with immune reactivation in 7 of 9 chimpanzees studied. These data make us very eager to see results as they emerge from MONARCH and our other multiple dose studies,” said Christopher Anzalone, Ph.D., Arrowhead president and CEO. “The goal of MONARCH is to identify one or more combinations of ARC-520 and other agents that enable functional cures in patients. If we can achieve this, it would represent a big leap forward in the field and provide hope for the more than 350 million people worldwide chronically infected with the hepatitis B virus.”
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.
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.
http://www.businesswire.com/news/home/20160107005349/en/Arrowhead-Begins-Dosing-Phase-2b-MONARCH-Combination
Wooow Aduski is it because you are telling the truth to the form in here? Thanks for the info though.
As ever studyforhope please if you can you explain "heart block" and the correlation to arc520?
1 Comments
what "heart block" ?
Have an Answer?
You are reading content posted in the Hepatitis B Community
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
