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Arrowhead Presents Data Showing Robust Sustained Anti-viral Effects with ARC-520 in Hepatitis B Infected Chimpanzees

PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, presents data at the AASLD Liver Meeting 2015® in an oral presentation and a poster showing that ARC-520, its drug candidate against chronic hepatitis B infection (HBV), leads to robust, sustained anti-viral effects in chimpanzees with chronic HBV. Arrowhead also describes an important new discovery that HBV DNA integrated into the host genome is likely an important source of HBV surface antigen (HBsAg) production, particularly in chimps that are negative for hepatitis B e-antigen (HBeAg). The company plans to present additional data from this study at the 2015 Hep Dart conference in December demonstrating that two of four HBeAg-positive chimps exhibited signs of immune reactivation, which is believed to be a necessary step toward achieving a functional cure of HBV.

“We believe that these data change current HBV biology dogma,” said Bruce D. Given, M.D., Arrowhead’s chief operating officer. “We have gained insights about the HBV life cycle during the chimpanzee study, and this has informed our clinical program for ARC-520. In addition, it has enabled us to expand our HBV portfolio to include ARC-521, our new drug candidate that may be highly active against HBsAg in patient populations with higher relative levels of integrated DNA.”

ARC-520 led to a dramatic drop in circulating HBsAg, with the degree of HBsAg reduction correlating with HBeAg status. HBeAg-positive and -negative chimps demonstrated HBsAg reductions of 1.5 - 2.7 log (96.8% - 99.8%) and 0.5 - 0.9 log (68.4% - 87.4%), respectively, with an intermediate response in a chimp transitioning from HBeAg positive to negative. In addition, one chimp seroconverted for HBeAg during ARC-520 therapy and had a sustained virologic response with respect to HBeAg, HBV DNA, and HBsAg. This persisted off therapy and through at least 32 weeks after ARC-520 and NUC therapy was removed, which was the last time-point observed. A second chimp demonstrated effects consistent with immunologic reactivation.

In the study, Arrowhead found that the predominant form of liver HBV DNA differed in...