NEW YORK, November 11, 2015 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for patients with chronic hepatitis B virus (HBV) and chronic HBV and hepatitis delta virus (HDV) co-infection, announces the publication of its preclinical data demonstrating the therapeutic effect of nucleic acid polymers (NAPs) in HBV infection in the journal PLOS ONE (http://dx.plos.org/10.1371/journal.pone.0140909).
This study, conducted in collaboration with Dr. Allison Jilbert at the University of Adelaide, Australia, assessed the antiviral effect of 28 days of daily treatment with Replicor’s first clinical candidate NAP (REP 2055) in Pekin ducks with previously established duck HBV (DHBV) infection. DHBV infection in Pekin ducks is a recognized surrogate model for HBV infection in humans. This study was the primary pre-clinical efficacy data that supported the use of NAPs (beginning with REP 2055) in Replicor’s proof of concept clinical trials in Asia.
In ducks with established DHBV infection, REP 2055 treatment was shown to reduce serum DHBV surface antigen (DHBsAg) to near or below undetectable levels within one week of treatment in all ducks and was associated with increased titers of antibodies to DHBsAg. This clearance of DHBsAg was shown to have a critical impact on the establishment of control of infection after treatment was halted: 55% (6/11) of treated ducks had no measurable DHBsAg and DHBV DNA in the blood by the end of treatment and for 16 weeks after treatment was halted, no evidence of viral antigens (DHBsAg and DHBV core antigen) were found in the liver, with covalently closed circular DNA (cccDNA), the transcriptional template of the virus, also becoming transcriptionally inactivated and reduced in copy number / hepatocyte by over 200 fold (~2.3 log) compared to the cccDNA copy number in hepatocytes in normal saline treated control animals.
Although several other approved antiviral agents for HBV (lamivudine, adefovir dipivoxil and entecavir) have been shown to have antiviral activity in the DHBV model, REP 2055 was the first antiviral agent to demonstrate rapid elimination of DHBsAg and to result in a sustained control of DHBV infection in a substantial proportion of treated ducks.
Replicor is a privately held biopharmaceutical company with the most advanced animal and human clinical data in the development of the cure for HBV and HDV. The company is dedicated to accelerating the development of an effective treatment for patients with HBV and HBV/HDV co-infection. For further information about Replicor please visit our website at www.replicor.com or follow us on Twitter @replicorinc.