Arrowhead Research Corp (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. (Original Source)
Shares of Arrowhead Research Corp. closed yesterday at $5.45, down $0.42 or -7.16%. ARWR has a 1-year high of $9.36 and a 1-year low of $4.35. The stock’s 50-day moving average is $5.91 and its 200-day moving average is $6.03.
On the ratings front, Arrowhead has been the subject of a number of recent research reports. In a report issued on December 10, Zacks Small-Cap Research analyst Grant Zeng maintained a Buy rating on ARWR, with a price target of $15, which represents a potential upside of 175.2% from where the stock is currently trading. Separately, on September 25, Piper Jaffray’s Edward Tenthoff reiterated a Buy rating on the stock and has a price target of $20.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Grant Zeng and Edward Tenthoff have a total average return of -33.5% and 4.6% respectively. Zeng has a success rate of 14.3% and is ranked #3445 out of 3630 analysts, while Tenthoff has a success rate of 37.9% and is ranked #764.
Arrowhead Research Corp is engaged in developing novel drugs to treat intractable diseases by silencing the genes. The Company’s drug candidate ARC-520 is designed to treat chronic hepatitis B infection.