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Clinical Trials

Date: 2015-04-23

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL)

Company: Medivir (Sweden)

Product: MIV-802

Action mechanism:

NS5B polymerase inhibitor/enzyme inhibitor/nucleotide analog. MIV-802 is a highly potent, pangenotypic nucleotide-based inhibitor of the HCV NS5B polymerase, which recently entered preclinical development. Preclinical data indicate that MIV-802 can be used effectively in combination with other classes of antiviral agents for the treatment of HCV, including protease inhibitors and NS5A inhibitors.

Disease: hepatitis C 

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news:

* On April 23, 2015, Medivir announced that the preclinical antiviral and safety profile of MIV-802, Medivir’s wholly-owned nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV) infection, was presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL), taking place in Vienna from April 22-26. The presentation, entitled “Preclinical characterization of MIV-802, a novel uridine nucleotide HCV NS5B polymerase inhibitor, for treatment of hepatitis C virus infection” (Abstract P0688), outlines the preclinical profile of MIV-802. This includes selective inhibition of the HCV NS5B polymerase by the active
metabolite of MIV-802 when compared with several human DNA and RNA polymerases, the potent and selective pan-genotypic inhibition of HCV RNA replication by MIV-802 in vitro, and its low toxicity in a range of in vitro and in vivo studies. The presentation also describes preclinical studies that show the selective delivery of high levels of the active metabolite of MIV-802 to the liver. The data therefore support the continuing development of MIV-802 for the future treatment of HCV infection in combination with other Direct Acting Antivirals (DAAs).
* On December 22, 2014, Medivir announced that MIV-802 has been selected as a candidate drug (CD) from its hepatitis C virus (HCV) nucleotide polymerase inhibitor project for the treatment of HCV infection, and is entering non-clinical development. Preclinical data indicate that it can be used effectively in combination with other classes of antiviral agents used to treat HCV, including protease inhibitors and NS5A inhibitors. MIV-802 has been designed to deliver large amounts of the drug selectively to the liver, where the hepatitis C virus replicates. Medivir expects to communicate the preclinical antiviral and pharmacokinetic profile of MIV-802 at a major scientific meeting in 2015.

Is general: Yes