Santaris Pharma to report new clinical data from miravirsen Phase 2a study on HCV

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA and mRNA-targeted therapies, today announced the Company will report new clinical data results from the miravirsen Phase 2a proof-of-concept study to treat patients infected with the Hepatitis C virus (HCV) in a late-breaking oral presentation session at the American Association for the Study of Liver Diseases (AASLD) 2011 annual meeting.

Data from the Phase 2a trial showed that miravirsen, the first microRNA-targeted drug to enter clinical trials, provided continuous and prolonged anti-viral activity well beyond the end of active therapy in patients and was well tolerated in patients infected with HCV. These data demonstrate that miravirsen has the potential to be a once-weekly treatment for chronic HCV infection.

The abstract titled, "A Randomized, Double-blind, Placebo Controlled Safety and Anti-viral Proof of Concept Study of Miravirsen, an Oligonucleotide Targeting miR-122, In Treatment Naive Patients with Genotype 1 Chronic HCV Infection" will be presented in a late-breaking oral presentation on November 7 at 4 p.m., at The Liver Meeting® 2011, the 62nd annual meeting of the AASLD, taking place from November 4-8 in San Francisco, California. The abstract is published on the AASLD website at http://aasld2011.abstractcentral.com/login.

The randomized, double-blind, placebo-controlled, ascending multiple-dose Phase 2a study assessed the safety and tolerability of miravirsen in treatment-naive patients with chronic HCV genotype 1 infection. Patients with chronic HCV genotype 1 infection were enrolled sequentially to one of three cohorts (9 active: 3 placebo per cohort). Miravirsen was given as weekly subcutaneous injections, over 29 days.

Key data that will be presented demonstrate that miravirsen was associated with dose-dependent, prolonged reductions in HCV RNA that continued to fall after the completion of miravirsen therapy. In Cohort 2, the mean of the maximum change from baseline in HCV RNA (log10 IU/mL) over the first 10 weeks was -2.710 vs -0.152 (p =0.020) in the miravirsen and placebo groups, respectively. In Cohort 2, five subjects had a greater than or equal to a 2 log10 decrease from baseline to week 10 and one patient became HCV RNA undetectable 10 weeks after the last dose of miravirsen (week 14) without the addition of standard-of-care (SOC). Cohort 3 is ongoing.