Arrowhead starts Phase I trial of hepatitis B therapeutic
ARC-520 is a RNA interference-based drug candidate that is meant to treat chronic HBV infection by reducing the expression and release of key viral proteins and new viral particles. The goals of the study are to evaluate pharmacokinetics in healthy volunteers, characterize the safety profile of ARC-520 and determine the maximum tolerated dose.
ARC-520 is the first drug candidate to use Arrowhead's proprietary dynamic polyconjugate delivery platform.
"This Phase I study will establish a safety profile for ARC-520 as well as provide the first human data for our DPC delivery platform," Christopher Anzalone, the president and CEO of Arrowhead, said. "This is an important step forward as we seek to advance ARC-520 into HBV patients and build additional RNAi therapeutics based on what we believe is the most potent delivery system in the industry."
Arrowhead anticipates the Phase I trial will be completed in the fourth quarter of 2013 and will be followed by a Phase IIa trial in chronic HBV patients next year.
Approximately 350 million people around the world are chronically infected with HBV, but there is no available treatment method to reliably achieve meaningful cure rates.
Arrowhead previously presented data generated in rodent models and in a chimpanzee chronically infected with HBV demonstrating ARC-520's induction of rapid deep and durable knockdown of both circulating HBV DNA and key viral proteins.