Replicor demonstrates high rates of persistent functional control of HBV infection following cessation of all therapy
MONTREAL, June 18, 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, presented updated mechanistic and clinical data last week at the Global Hepatitis Summit 2018 (16th International Symposium on Viral Hepatitis and Liver Disease) held June 14-17, 2018 in Toronto, Canada.
The latest follow-up data was presented from the REP 401 trial (NCT02565719) assessing the safety and efficacy of 48 weeks of combination therapy with REP 2139-Mg or REP 2165-Mg, pegylated interferon α-2a (pegIFN) and tenofovir disoproxil fumarate (TDF). In patients completing 24 weeks of treatment-free follow-up, functional repression (HBV DNA < 1000 IU/mL) is present in 87% of patients (79% of these with HBsAg < 10 IU/mL) and functional remission (HBV DNA < LLOQ) is present in 70% of patients (66% of these with no detectable HBsAg [0.00 IU/mL]). Liver function is normal in 92% of these patients. Dr. Andrew Vaillant, CSO, commented “REP 2139’s ability to rapidly reduce HBsAg in 90% of patients is unique in the industry and is accompanied by immediate reductions of viremia in the blood and viral replication in the liver. In pre-clinical studies, this effect alone has led to complete control of and profound reduction of cccDNA in the liver.”
Combination therapy in the REP 401 trial was well tolerated and paves the way for the transition of REP 2139-Mg to a subcutaneous administration route. PegIFN was well tolerated with only mild side-effects and lead to a striking reactivation of immune response against HBV infection, with profound increases in anti-HBs, the appearance of therapeutic transaminase flares and the establishment of functional control. Dr. Vaillant went on to comment, “The tolerability of pegIFN in the REP 401 trial was substantially better than when used with ribavirin in HCV infection. Although other immunotherapies will be assessed in future combination settings, the inclusion of pegIFN in REP 2139-Mg based combination therapy represents an option with clear clinical activity and benefit that can give patients access to the first effective finite therapy for HBV and HDV infection.”
Replicor Next steps:
•REP 103 / A5382 trial in the US (in collaboration with ACTG): REP 2139-Mg + PegIFN in NUC supressed patients
•Transition REP 2139-Mg to SC administration
•REP 2139-Mg + TDF + pegIFN in HBV / HDV co-infection
•Compare other immunotherapies to pegIFN in this combination therapy setting
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