Hepatitis C

Single dose cure for Hepatitis C

Market

Hepatitis C virus (HCV) infects over 170 million people worldwide, and is the main cause of cirrhosis, hepatocellular carcinoma and liver transplant.  There are 7 HCV genotypes, and genotype 1 accounts for 75% of cases. The virus persists in the liver of 85% of those infected and, prior to July 2011, the Standard of Care (SoC) for genotype 1 was pegylated-interferon (PEG-interferon) and ribavirin administered over 48 weeks. The SoC had a cure rate of 50-55% yet was associated with significant side effects including hematological, flu-like symptoms, and cognitive impairment.

Since July 2011, cure rates of up to 75% have been achieved by combining Specifically Targeted Antiviral Therapy (STAT-C) with PEG-interferon and ribavirin, also administered over long periods. However, a significant percentage of patients has either withdrawn due to side effects, or not responded.

Rationale

Tacere has designed a ddRNAi –based multi-cassette vector called TT-034 which targets 3 parts of the HCV genome in a single intravenous dose. TT-034 has achieved over 90% transfection of liver cells and, by targeting 3 separate, well-conserved regions of HCV simultaneously, it prevents generation of drug-resistant mutants, a major problem in the treatment of Hepatitis C. The targeted regions of HCV are also conserved across all genotypes, so TT-034 has likely application to all HCV-caused conditions. Read more about TT-034 here.

Status

Tacere is advancing TT-034 to the clinic via these important steps:

  • Submission of the clinical trial protocol to the NIH’s Recombinant DNA Advisory Committee (RAC) in June 2013 and gaining favourable feedback. See the full proceedings of the meeting here.
  • Application for Investigational New Drug (IND) with the FDA in December 2013
  • Advice from the US FDA in January 2014 that the clinical trial can proceed
  • The first dosing of TT-034 in human patients is expected in 2014.

Publications

  1. Safe, Long-term Hepatic Expression of Anti-HCV shRNA in a Nonhuman Primate Model
    Suhy DA, Kao SC, Mao T, Whiteley L, Denise H, Souberbielle B, Burdick AD, Hayes K, Wright JF, Lavender H, Roelvink P, Kolykhalov A, Brady K, Moschos SA, Hauck B, Zelenaia O, Zhou S, Scribner C, High KA, Renison SH, Corbau R.
    Mol Ther. 2012 Sep;20(9):1737-49. Epub 2012 Jun 26.
    Read abstract. Download PDF
  2. In vitro characterization of the activity of PF-05095808 a novel biological agent for Hepatitis C Virus therapy.
    Lavender H, Brady K, Burden F, Delpuech-Adams O, Denise H. Palmer A, Hannah Perkins H, Savic B, Scott S, Smith-Burchnell C,Troke P, Wright JF, Suhy D, Corbau R.
    Antimicrob Agents Chemother. 2012 Mar; 56(3):1364-75.
    Read abstract. Download PDF

 

 

 
 
 

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