MONTREAL, Feb 20, 2017 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, presented an updated interim analysis from its latest REP 401 clinical trial at the Asia Pacific Association for the Study of Liver (APASL) held February 15-19, 2017 in Shanghai, China.
The REP 401 protocol (NCT02565719) is a randomized, controlled trial assessing the safety and efficacy of its first in class nucleic acid polymer (NAP) HBsAg release inhibitors, REP 2139 and REP 2165 in combination with tenofovir disoproxil fumarate (TDF) and pegylated interferon alpha-2a (peg-IFN) in treatment naïve patients with chronic HBeAg negative HBV infection.
In patients receiving NAPs in combination with TDF and peg-IFN, 8/9 patients receiving REP 2139 have experienced HBsAg reductions > 4 logs with HBsAg loss (HBsAg ≤ 0.01 IU / ml) in 7 of these patients. With REP 2165, a REP 2139 variant with improved tissue clearance, 6/10 patients have > 4 log reductions in HBsAg with loss occurring in 5 of these patients. Anti-HBs levels as high as 2422 mIU / mL accompany these HBsAg reductions.
Patients completing 24 weeks of peg-IFN + TDF have crossed over to triple combination therapy with NAPs after experiencing minimal HBsAg response. Crossover patients receiving either NAP are experiencing early, multiog reductions in HBsAg and increases in anti-HBs similar to the initial NAP responses seen in the experimental group. NAP-based triple combination therapy continues to be well tolerated in all patients with both NAPs.
This interim update from the REP 401 trial continues to demonstrate that NAPs have a unique and unsurpassed ability to safely clear serum HBsAg, substantially improving antiviral response to immunotherapy and allowing the achievement of functional control of both HBV and HDV infection.
Replicor’s presentation from APASL 2017 is available on the company’s website at www.replicor.com/science/conference-presentations. For further information about the 2017 APASL Meeting visit: http://www.apasl2017.org/#/.
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.