MONTREAL, October 23, 2017 – 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 first interim follow-up data from its REP 401 study at the 2017 meeting of the American Association for the Study of Liver Disease (AASLD) held October 20-24, 2017 in Washington, DC, U.S.A.
Interim follow-up data from the REP 401 protocol (NCT02565719) was disclosed today at Replicor’s late breaking poster presentation (LB-24). Of experimental patients receiving REP 2139, tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha 2a (peg-IFN), 8/10 attained functional control of infection at the end of treatment (HBsAg < 1IU/mL, HBV DNA < 10IU/mL) which was accompanied by therapeutic liver flares and the appearance in the blood of substantial titers of anti-HBsAg antibodies up to 223,055 mIU/mL. This functional control is persisting in all patients (80%) after removal of all therapy with data available for 24 weeks in 4 patients, 12 weeks in 3 patients and 4 weeks in 1 patient.
Dr. Andrew Vaillant, CSO of Replicor commented, “recent clinical studies have shown that TDF and pegIFN combined achieve HBsAg clearance in less than 10% of patients. The addition of REP 2139’s unique ability to clear circulating HBsAg improves this outcome in a striking fashion, achieving functional control in 80% of patients not only during treatment but persisting after treatment is withdrawn.” Dr. Vaillant went on to add, “equally important is the normalization of liver function during follow-up in all these patients, even those with significantly elevated liver enzymes at the start of therapy.”
Current follow-up data already shows that 4 patients have met the new endpoints for functional cure of HBV infection (HBsAg loss and HBV DNA < 1000 copies / mL for 6 months after withdrawal of therapy) as recently suggested by the joint AASLD/EASL working group and this number of patients is expected to rise as additional follow-up data becomes available.
Replicor’s presentation from the REP 401 trial as well as its other presentations updating its mechanistic studies of NAPs in HBV and HDV infections 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