Replicor announces publication of its REP 101 and REP 102 studies demonstrating the therapeutic effect of NAPs and the achievement of functional control off treatment in human patients with chronic hepatitis B infection.
NEW YORK, June 7, 2016 – 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, announces the publication of clinical data from its REP 101 and REP 102 studies demonstrating the therapeutic effect of nucleic acid polymers (NAPs) in patients with HBeAg positive chronic HBV infection in the journal PLOS ONE (http://dx.plos.org/10.1371/journal.pone.0156667).
The REP 101 study (NCT02646163) assessed the safety and efficacy of Replicor’s first clinical NAP candidate, REP 2055, as a weekly monotherapy in patients with HBeAg positive chronic HBV infection. The follow-on REP 102 study (NCT02646189), conducted in similar patients, used an improved NAP candidate (REP 2139) in an improved formulation with better administration tolerability (REP 2139-Ca) and included transition from monotherapy to brief (13-26 weeks) combination therapy with thymosin alpha 1 or pegylated interferon alpha 2a.
In both studies, NAP monotherapy was accompanied by 2 – 7 log reductions of serum HBsAg, 3 – 9 log reductions in serum HBV DNA, seroconversion of HBeAg and the appearance of serum anti-HBsAg antibodies. Self-resolving flares in liver transaminases in many patients (considered indirect evidence of antiviral immune activity in the liver) which peaked during the clearance of serum viremia were also observed. In the REP 102 study, 9 patients transitioned to combined treatment with immunotherapy during which 8 experienced HBsAg loss and all 9 experienced rapid and dramatic increases in serum anti-HBsAg antibody titers before withdrawal of therapy.
After REP 2055 treatment, 3 / 8 patients maintained control of infection for 1 year and two of these patients have still maintained control 5 years off-treatment. After combination therapy in the REP 102 study, 8 of 9 patients maintained control of infection after treatment which has persisted for more than 2 years in four of these patients.
Based on these initial studies, an optimized NAP-based combination therapy is currently being evaluated in HBeAg negative chronic HBV infection in the REP 401 protocol (NCT02565719), which has the potential to more easily achieve the functional control of chronic HBV infection with a finite course of treatment.
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.