MONTREAL, Nov 15, 2016 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, today presented its preliminary interim analysis from its latest REP 401 clinical trial at the American Association for the Study of Liver Disease (AASLD) during the late-breaking oral abstract session at its annual meeting held November 11-15, 2016 in Boston, U.S.A.,
The REP 401 protocol (NCT02565719) is a randomized, controlled trial assessing the safety and efficacy of its first in class HBsAg release inhibitor, REP 2139 and a REP 2139 derivative with improved plasma and tissue clearance (REP 2165) in combination with tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha-2a (peg-IFN) in treatment naïve patients with chronic HBeAg negative HBV infection.
Control patients receiving peg-IFN + TDF exhibited minimal antiviral response beyond suppression of serum HBV DNA. Patients receiving REP 2139 or REP 2139 in addition to peg-IFN and TDF experienced robust, multilog reductions in HBsAg, increased levels of circulating anti-HBsAg antibodies and serum transaminase flares indicating restored immune response in the liver.
Replicor also presented its complete 6 month follow-up data from the REP 301 protocol (NCT02233075) assessing the safety and efficacy of REP 2139 in combination with peg-IFN in patients with chronic HBV / HDV co-infection. After 24 weeks of follow-up, despite the use of a suboptimal combination regimen, 5/12 patients had no detectable HBsAg and 7/12 patients had no detectable HDV RNA, indicating that functional control of infection has been established in these patients.
These presentations confirm Replicor’s previous proof of concept clinical trial data and demonstrate that its nucleic acid polymer technology has a unique ability to clear serum HBsAg, substantially improve antiviral response to immunotherapy and to achieve functional cure of both HBV and HDV infection.
Replicor’s presentations from AASLD 2016 will be available on the company’s website following their disclosure at the meeting at www.replicor.com/science/conference-presentations. For further information about the 2016 AASLD Meeting visit: http://www.aasld.org/events-professional-development/liver-meeting.
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.