New York – October 4, 2015 – Replicor announces that the recruitment of patients is underway for its second Phase II trial in Caucasian patients that will assess the safety and antiviral efficacy of REP 2139-Mg or REP 2165-Mg in combination with Viread® and Pegasys® or Zadaxin® in patients with HBeAg negative chronic hepatitis B infection.
The design of the REP 401 protocol (NCT02565719) draws on Replicor’s experience with REP 2055 and REP 2139-Ca from its 4 previous Phase II trials in Asian and Caucasian patients with HBV or HBV / HDV infection. This randomized controlled trial will introduce the next generation formulation of REP 2139 (REP 2139-Mg) and a new NAP, REP 2165 (as REP 2165-Mg). REP 2165 is a version of REP 2139 designed to be more rapidly eliminated from the body which in pre-clinical evaluations showed similar antiviral activity with significantly reduced accumulation in the liver compared to REP 2139.
The EU GCP compliant REP 401 protocol is being conducted in Moldova and will consist of 60 Caucasian patients with HBeAg negative chronic HBV infection, all of whom will receive 24 weeks of Viread® exposure before entering the combination phase of therapy. 30 of these patients (while continuing Viread® therapy) will be randomized into three experimental arms:
REP 2139-Mg + Pegasys® for 48 weeks
REP 2139-Mg + Zadaxin® for 48 weeks
REP 2165-Mg + Pegasys® for 48 weeks.
The other 30 patients will be randomized into comparator control arms receiving either Pegasys® or Zadaxin® (in the absence of NAP therapy) in addition to continuing Viread®. All patients in the comparator control arms demonstrating futility of therapy (as defined by < 3 log reduction in serum HBsAg from baseline after receiving 24 weeks combination therapy) will be eligible for randomized crossover to an experimental arm to receive 48 weeks of NAP therapy while continuing their current combination therapy. Follow up assessment after halting all treatment is planned for 48 weeks.
For more information please visit the clinicaltrials.org website:
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 infection. For further information about Replicor please visit our website at www.replicor.com and follow us on Twitter @replicorinc.
* The study is conducted by Clinical Accelerator