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 < 1 IU / ml (> 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:
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 infection. For further information about Replicor please visit our website at www.replicor.com.