miravirsen

Research Published in the New England Journal of Medicine Demonstrates Marked and Long-Lasting Antiviral Activity Against HCV for Santaris Pharma A/S’ Miravirsen, the First MicroRNA-Targeted Drug to Enter Clinical Trials

Santaris Pharma LogoHOERSHOLM, Denmark and SAN DIEGO, March 27, 2013 /PRNewswire/ — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced the publication of study results online in the New England Journal of Medicine (NEJM). The publication highlights the potential benefits of miravirsen, a host-targeted, pan-HCV genotype anti-viral agent and the first microRNA-targeted drug to enter clinical trials for the treatment of Hepatitis C virus (HCV). In the study, miravirsen, given as a four-week monotherapy treatment, provided robust dose-dependent antiviral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL). The effect was sustained well beyond the end of therapy.

Clinical data from the Phase 2a study demonstrated the following:

  • Miravirsen was safe, well tolerated and provided prolonged antiviral activity well after the last dose of miravirsen monotherapy (x5 weekly injections)
  • There were no signs of viral resistance
  • Adverse events were infrequent, mild and did not lead to study drug discontinuation
  • There were no dose limiting toxicities or discontinuations due to adverse events
  • Miravirsen was associated with dose-dependent reductions in [click to continue…]

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Santaris Pharma A/S announced today that it has advanced miravirsen (SPC3649), a microRNA targeted drug for treatment of  Hepatitis C virus (HCV) infection into Phase 2 studies to assess the safety and tolerability of the drug.

Santaris Pharma A/S also received acceptance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). In addition to the United States, the Phase 2a clinical trials will be conducted in the Netherlands, Germany, Poland, Romania, and Slovakia.

Miravirsen is a specific inhibitor of miR-122, a liver specific microRNA that the Hepatitis C virus requires for replication. Miravirsen is designed to recognize and sequester miR-122, making it unavailable to the Hepatitis C virus. As a result, the replication of the virus is effectively inhibited and the level of Hepatitis C virus is reduced.

In addition to miravirsen, Santaris Pharma A/S is developing other drugs targeting mRNAs and microRNAs both internally as well as in partnerships and collaborations with miRagen Therapeutics (cardiovascular diseases), Shire plc (rare genetic disorders), Pfizer (undisclosed therapeutic areas), GlaxoSmithKline (viral disease) and Enzon Pharmaceuticals (oncology).  (read more… )

It’s only a matter of time before the first microRNA therapeutic reaches the market.

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