SAN DIEGO - Anadys Pharmaceuticals Inc. announced in a press release issuance of the US patent covering setrobuvir (ANA598), the Company’s Direct-Acting Antiviral (DAA) in Phase IIb development for chronic hepatitis C virus infection (HCV).
US Patent No. 7,939,524, granted to Anadys by the United States Patent and Trademark Office, recognizes the Company’s intellectual property rights to the composition of matter and methods of use for setrobuvir (ANA598) and related compounds.
“Securing US patent protection is a critical step that significantly enhances the value of setrobuvir,” said Steve Worland, president and CEO of Anadys. “This milestone comes at an important juncture in the setrobuvir development program, as we complete enrollment of our Phase IIb trial and begin the investigation of setrobuvir in combination with other DAAs.”
Setrobuvir (ANA598), the Company’s wholly-owned DAA, is currently in Phase IIb testing in combination with pegylated interferon and ribavirin for the treatment of HCV. Anadys recently announced a cross-company clinical trial agreement with a large, commercial-stage biopharmaceutical company to study setrobuvir (ANA598) in combination with another DAA in healthy volunteers.
Setrobuvir is the name recently adopted for ANA598 by the United States Adopted Names (USAN) Council.
Setrobuvir (ANA598) is an HCV RNA polymerase inhibitor that belongs to a chemical class referred to as non-nucleosides. Setrobuvir has a well-characterized safety database in which more than 150 subjects have received the agent to date. Setrobuvir (ANA598) has received Fast Track Status from the FDA for the treatment of chronic hepatitis C.
In the ongoing Phase IIb study, setrobuvir (ANA598) is being tested in combination with Pegasys® and Copegus® in both treatment-naïve patients and patients who failed a prior course of therapy with interferon and ribavirin. Dosing is underway and approximately 275 patients are expected to be enrolled in the study.
The primary endpoint of the study is Sustained Virological Response 24 weeks after patients complete treatment, known as SVR24. The Company expects to receive antiviral response data through 12 weeks for all patients, including the 8 week timepoint used for response-guided therapy in treatment-naïve patients, in the third quarter of 2011.
Antiviral response data through 24 weeks are expected in the fourth quarter of 2011.
Prior Clinical and Preclinical Profile of Setrobuvir (ANA598)
In an earlier Phase IIa study, setrobuvir (ANA598) demonstrated potent antiviral activity, as well as good safety and tolerability in combination with interferon and ribavirin through 12 weeks of dosing in treatment-naïve genotype 1 HCV patients. In a completed Phase I study, setrobuvir demonstrated potent antiviral activity in a three day monotherapy study in treatment-naïve genotype 1 patients. To date, setrobuvir has demonstrated an excellent resistance profile in HCV patients.
Setrobuvir (ANA598) has also been characterized in a variety of preclinical studies. In completed longterm chronic toxicology tests in both rats and monkeys, the No Observed Adverse Effect Level, or NOAEL, was 1000 mg/kg, the highest dose tested. Data from preclinical models of antiviral activity have laid the foundation for clinical investigation of setrobuvir (ANA598) in DAA combinations. In particular, synergistic antiviral activity in vitro was observed when setrobuvir (ANA598) was combined with a number of approved or investigational HCV agents, and in vitro combinations of setrobuvir
(ANA598) with other DAAs from multiple classes resulted in clearance of HCV RNA from cells rather than selection of resistant isolates.
Anadys Pharmaceuticals Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C.