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–(BUSINESS WIRE)– 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.

About Replicor

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.

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