Medivir announces start of a phase I clinical trial of the nucleotide polymerase inhibitor AL-704 for treatment of hepatitis C
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces the start of a phase I clinical trial with AL-704, also known as JNJ-54257099, by Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies. AL-704 is a nucleotide based NS5B polymerase inhibitor intended for the treatment of chronic hepatitis C virus (HCV) infection in combination with other direct acting antiviral agents.
Medivir entered a Research & Development agreement in the field of HCV polymerase with Janssen Products LP in May 2008. AL-704 is the second candidate drug under this agreement that enters into clinical development, and thus no additional milestone payment is due for this specific step of development.
This phase I study is a randomized, double-blind, placebo-controlled, 3-part study of orally administered AL-704 to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses (Part 1) and food-effect (Part 2) in healthy volunteers, and multiple doses (7 days) in subjects with chronic hepatitis C infection of genotype 1 and 3 (Part 3).
Approximately 150 million people are chronically infected with HCV globally*. When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation. However the infection is curable with combinations of antiviral agents, and nucleotide inhibitors of the viral polymerase have been shown to be central to some of the most effective drug combinations for treating HCV.
Further information about the study can be found at www.clinicaltrials.gov
For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0)725-480 580.
Medivir is required under the Securities Markets Act to make the information in this press release public.
The information was submitted for publication at 17.00 CET on 29 July 2015.
Medivir is a research based pharmaceutical company with a research focus on infectious diseases and oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a growing portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.