Replicor announces initiation of its Phase II clinical trial with REP 2139-Ca in combination with Pegasys™ in patients with hepatitis B / hepatitis D co-infection
October 1, 2014 – Replicor announces that the recruitment of patients is underway for its Phase II trial assessing the safety and antiviral efficacy of REP 2139-Ca in combination with Pegasys™ in patients with hepatitis B / hepatitis D (HBV / HDV) co-infection. HDV infection only occurs in patients with an existing HBV infection because HDV requires the HBV surface antigen protein for its reproduction. Effective treatment for HBV / HDV co-infection is an urgent unmet medical need as the progression of liver disease in HBV / HDV co-infection is substantially more aggressive than HBV or HCV infection and none of the currently marketed antiviral agents for HBV, whether used alone or in combination, has the ability to treat this co-infection.
The REP 301 protocol (NCT02233075) is being conducted in 12 Caucasian patients in Moldova with HBV / HDV co-infection and involves 15 weeks of monotherapy with REP 2139-Ca, followed by 15 weeks of combination therapy with REP 2139-Ca and Pegasys™ followed by 33 weeks of consolidation therapy with Pegasys™ alone. Full details of the REP 301 trial can be found at: