Date: 2013-08-27
Type of information:
phase: 2
Announcement: completion of patient recruitment
Company: Santaris Pharma (Denmark)
Product: miravirsen
Action mechanism: Miravirsen is a microRNA-targeted drug. Developed using Santaris Pharma proprietary Locked Nucleic Acid (LNA) Drug Platform, miravirsen is an inhibitor of miR-122, a liver specific microRNA critical for Hepatitis C virus RNA accumulation in the liver. Miravirsen is designed to recognize and sequester miR-122, making it unavailable to the Hepatitis C virus. As a result, the level of Hepatitis C virus is profoundly reduced.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country:
Trial details: The Phase 2, open-label study assesses the safety, antiviral activity and pharmacokinetics of miravirsen monotherapy over a total of 12 weeks of treatment. Patients enrolled in the study were chronically infected with HCV genotype 1 and had previously failed treatment with peg-IFN?/RBV therapy. Miravirsen was given as a total of five doses over five weeks, followed by a further four doses once every other week over seven weeks.
Latest
news: * On August 27, 2013, Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, has announced the completion of enrollment of its Phase 2 miravirsen 12-week monotherapy study of miravirsen in subjects who were “null responders” to pegylated interferon alpha and ribavirin (peg-IFN?/RBV). The company also announced the enrollment of the first patient into another Phase 2 study of miravirsen in combination with telaprevir and ribavirin, also in null responders to peg-IFN?/RBV.
