MONTREAL, April 13, 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 today the evolving long-term follow-up data from its REP 301-LTF and REP 401 studies at the 2018 International Liver Conference of the European Association for the Study of the Liver (EASL) held April 11-15, 2018 in Paris, France.
Long term follow-up after completion of REP 2139-based combination therapy with pegylated interferon (pegIFN) or pegIFN and TDF is now extended up to 48 weeks in the REP 401 (NCT02565719) and up to 2 years in the REP 301-LTF (NCT02876419) protocols being conducted in patients with in HBeAg negative chronic HBV infection and HBV/HDV co-infection respectively.
In REP 401 patients completing treatment and at least 12 weeks of follow-up, functional control of HBV infection (HBV DNA < 1000 IU/mL or HBV DNA< LLOQ) currently persists in 25/33 patients (75%). In patients with HBV/HDV co-infection completing treatment (with only a 15 week overlap of REP 2139-Ca and pegIFN) and 1.5-2 years of follow-up, functional control of HDV infection (HDV RNA target not detectable) currently persists in 7/11 patients (64%). Functional control of HBV infection also persists in 6/7 of these patients (86%). In both trials, liver function during follow-up is persistently normal in most patients. In the REP 401 study, HBsAg reductions of > 4 log from baseline during therapy were highly correlated with persistent functional control during follow-up.
Dr. Andrew Vaillant, CSO of Replicor commented, “the evolving follow-up analysis in these studies, continues to demonstrate the well tolerated nature of REP 2139-based combination regimens during treatment and during long-term follow-up, with clear improvement of liver function.” Dr. Vaillant went on to add, “the continued positive clinical impact of profound reductions in HBsAg to below 1 IU/mL in restoring functional control of HBV and HDV infection in most patients illustrates the importance of this milestone in predicting positive treatment outcomes.”
Replicor’s presentations from EASL 2018 from the REP 301-LTF and REP 401 trials as well as an update on its ongoing collaboration with Dr. Harel Dahari at Loyola University on modeling viral kinetics in response to REP 2139 therapy are now available at www.replicor.com/science/conference-presentations.
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.
* The study is conducted by Clinical Accelerator