A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylaat Administered with Ribavirin

Although effectiveness varies for subpopulations, standard-of-care treatment
can durably clear HCV infection in only about 50% of treated
genotype 1 patients and has significant side-effects that often result in early
abandonment of treatment. Thus, there remains a need for new anti-HCV therapies
to improve response rates and tolerability.
Immune response plays an important role in controlling and/or possibly clearing
chronic
viral Hepatitis infections ANA773 tosylate (ANX8414), an orally administered
prodrug of a TLR7 agonist which stimulates
the innate immune response, may therefore offer therapeutic benefit in treating
patients with chronic HCV infection, either in combination with standard of
care treatments or when combined with direct-acting antiviral agents.

- to evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414)
administered with ribavirin in
patients with chronic hepatitis C viral (HCV) infection
· to evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate
(ANX8414) administered with
ribavirin in patients with chronic HCV infection.
· to evaluate different dosing schedules of ANA773 tosylate (ANX8414)
administered with ribavirin in
patients with chronic HCV infection.

This will be a randomized, open-label, multiple dose study to evaluate the
safety, tolerability, pharmacodynamics,
and antiviral activity of ANA773 administered with ribavirin (ANA773 +
ribavirin) following oral administration to
patients with chronic HCV infection.

Medication:
- 2000mg ANA773 tosylate for 26 or27 days, combined with ribavirin (bodyweight<
75 kg: 1000 mg and bodyweight>75 kg: 1200 mg);
-Standard of Care therapy: pegylated interferon (180 mcg) with ribavirin.

ANA773 tosylate (ANX8414):
flu-like symptoms (fever, chills, myalgia), headache, lymphocytopenia,
thrombocytopenia, increased APTT.

Ribavirin:
Aneamia, itchine and rash

Pegays:
fever, chills, rash, itching, painfull or swollen joints, low bloodpressure,
increase ALT, neutropenia, thrombocytopenia and (worsening of ) depression.