MONTREAL, November 21st, 2018 – 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 new data validating the clearance of HBsAg in response to NAP therapy in the Journal of Viral Hepatitis (https://onlinelibrary.wiley.com/doi/pdf/10.1111/jvh.13044).
The article is entitled “Variants of hepatitis B virus surface antigen observed during therapy with nucleic acid polymer REP 2139‐Ca have no influence on treatment outcome and its detection by diagnostic assays.” This study adds to data previously published from Replicor’s ongoing collaboration with Dr. Michael Roggendorf at the Technical University of Munich (TUM), Germany, confirming that the HBsAg reductions and loss of HBsAg which uniquely occur in a high proportion of patients receiving REP 2139 are real.
Dr. Andrew Vaillant, CSO at Replicor commented, “From the initiation of our first clinical study, NAP-based combination therapy was the first, and, is still the only therapeutic approach that consistently demonstrates high rates of rapid serum HBsAg reduction and loss and restoration of control of HBV and HDV infection in the absence of therapy. Understandably, these results led to some skepticism concerning the validity of the HBsAg losses occurring with REP 2139. Early on in the clinical development of NAPs, we turned to Dr. Roggendorf and the virology group at TUM to demonstrate that these HBsAg losses are real and this publication is the second from this ongoing collaboration to show that REP 2139-mediated HBsAg loss is real.”
Previously published data in The Lancet Gastroenterology & Hepatology (https://www.thelancet.com/journals/langas/article/PIIS2468-1253(17)30288-1/fulltext) demonstrated that REP 2139 does not interfere with a broad suite of protein and nucleic acid-based assays for HBV and HDV. In the current study, HBsAg strains which cannot be detected by the industry standard HBsAg test platforms used in Replicor’s clinical studies were not observed at any time during REP 2139 exposure. These data confirm the validity of HBsAg responses observed in all clinical studies with REP 2139-Ca or REP 2139-Mg.
Dr. Vaillant added, “This study also showed that HBsAg sequences present in different participants at baseline had no influence on their HBsAg response to REP 2139, consistent with our data showing that NAPs effect the assembly and secretion of subviral particles by interfering with a host protein involved in their formation.”
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.