Replicor Announces Completion of Enrollment in Phase II Trial

NEW YORK, April 2, 2015 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, today announced the completion of enrollment in its latest phase II proof of concept trial (REP 301 protocol). This trial will examine the safety and efficacy of combined REP 2139-Ca and Pegasys® (peginteferon alfa-2a) treatment in patients with chronic hepatitis B / hepatitis D co-infection.

The REP 301 protocol (NCT02233075) is examining the safety and efficacy of REP 2139-Ca monotherapy followed by combination therapy with REP 2139-Ca and Pegasys® in patients with chronic hepatitis B / hepatitis D co-infection. This proof of concept trial is designed to achieve the following milestones:

1. Demonstrate the safety of REP 2139-Ca in monotherapy and when combined with Pegasys® in Caucasian patients.

2. Confirm the pharmacological effect of REP 2139-Ca (HBsAg release inhibition) observed in previous Asian trials (REP 102 and 201 protocols) in Caucasian patients.

3. Demonstrate combined antiviral efficacy against both hepatitis B and hepatitis D infections.

4. Assess SVR rates achievable with REP 2139-Ca / Pegasys® combination therapy.


Source:  http://replicor.com/replicor-announces-completion-enrollment-phase-ii-trial/

Labels: ,