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Regulus Therapeutics Expands Worldwide Patent Coverage on microRNA-122 to Treat Hepatitis C Virus (HCV) Infection
Date:11/2/2011

stralia following issuances in Europe and the United States. This further exemplifies Regulus' leading intellectual property portfolio in the field of microRNA therapeutics. Recent clinical data in the field has demonstrated that inhibiting miR-122 with an oligonucleotide is safe, well tolerated, and able to reduce viral titers. That data, in combination with Regulus' data demonstrating potent inhibition with a proprietary anti-miR having favorable pharmacokinetic properties, supports the development of anti-miR-122 for the treatment of HCV in combination with other anti-virals," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Regulus Therapeutics. "The HCV landscape has undergone a tremendous amount of transformation with the recent emergence of new direct-acting antivirals.  Anti-miR-122 is attractively positioned because it targets a host factor that is essential for viral replication and therefore may be resistant to viral mutation and escape."

miR-122 is a liver-expressed microRNA that has been shown to be a critical endogenous "host factor" for the replication of HCV, and anti-miRs targeting miR-122 have been shown to block HCV infection (Jopling et al. (2005) Science 309, 1577-81). In earlier work, scientists at Alnylam Pharmaceuticals and Isis Pharmaceuticals (Regulus' co-founders) demonstrated the ability to antagonize miR-122 in vivo using chemically modified single-stranded anti-miR oligonucleotides. Data from multiple preclinical studies have shown a robust HCV antiviral effect following inhibition of miR-122.  In February 2010, Regulus and GlaxoSmithKline entered into a new collaboration to develop and commercialize microRNA therapeutics targeting microRNA-122 for the treatment of hepatitis C infection.

Regulus is advancing multiple other microRNA therapeutic programs to the clinic in the areas of fibrosis, immuno-inflammatory disease, metabolic disease, and oncology.

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