Replicor to present pre-clinical and clinical data on REP 2139-Ca based combination therapy in chronic HBV / HDV co-infection at HEPDART 2015
NEW YORK, December 1, 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, will present preclinical and clinical data on REP 2139-Ca based combination therapies in HBV monoinfection and HBV / HDV co-infection at the 2015 HEPDART meeting to be held from December 6-10, 2015 in Wailea, Hawaii. These presentations will be made during the poster session on December 8th.
Poster #114 will present the preclinical assessment of interferon-free combination therapy with REP 2139-Ca and tenofovir disoproxil fumarate (TDF) and entecavir (ETV) to establish control of HBV infection in the liver using the duck model of HBV infection. In this study, combining REP 2139-Ca with TDF and ETV improved the speed of on-treatment antiviral response and lead to the control of infection in the liver of most ducks including multi-log reductions in liver DHBV DNA and cccDNA and disappearance of duck HBsAg from the liver.
Poster #60 will present the interim efficacy data from the ongoing REP 301 trial (NCT02233075) assessing the safety and efficacy of REP 2139-Ca used in combination with pegylated interferon alpha 2a in Caucasian patients with HBV / HDV co-infection. HBsAg reductions during combined therapy with REP 2139-Ca and pegylated interferon alpha-2a continued to decline, becoming > 6 logs in 4 patients (0.01 IU / ml), > 5 logs in 2 patients, > 3 logs in 2 patients and 0.5-2.78 logs in the remaining 4 patients. HDV RNA is now currently undetectable in ten patients (~5-8 log reduction from baseline). The addition of pegylated interferon alpha-2a to therapy was associated with dramatic increases in free anti-HBs (to levels as high as 20,665 mIU / ml) and liver flares, but only in those patients who achieved serum HBsAg 4 log reduction from baseline) at the start of immunotherapy.
These pre-clinical and clinical studies continue to advance Replicor’s understanding of how different REP 2139-Ca based combination therapies will benefit patients with HBV infection or HBV / HDV co-infection.
For the HEPDART 2015 meeting and preliminary program: