MONTREAL, QC-Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, presented its preliminary interim analysis from its latest REP 401 clinical trial at the American Association for the Study of Liver Disease (AASLD) annual meeting held November 11-15, 2016 in Boston, MA.
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 six 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.
According to the company, these presentations confirm its 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, which could achieve a functional cure of both HBV and HDV infection.