Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

Summary

REP 9AC (REP 2055) is a nucleic acid polymer (NAP) with entry and post-entry antiviral activity against duck hepatitis B virus (DHBV) infection. REP 2055 has been shown to have potent therapeutic effect against established DHBV infection in vivo REP 2055 was additionally shown to have significant antiviral effects in patients with chronic HBV infection in the previous REP 101 study. REP 2139 is a version of REP 2055 designed for improved administration tolerability and stability. The safety and antiviral activity REP 2139, first in monotherapy and then in combination with immunotherapy in patients with chronic HBV infection will be assessed in the REP 102 protocol.

Timeline

Start

2011-08

Primary completion

2013-08

Completion

2013-08

Publications

• Background Noordeen F, Vaillant A, Jilbert AR. Nucleic acid polymers inhibit duck hepatitis B virus infection in vitro. Antimicrob Agents Chemother. 2013 Nov;57(11):5291-8. doi: 10.1128/AAC.01003-13. Epub 2013 Aug 12.
• Background Noordeen F, Vaillant A, Jilbert AR. Nucleic acid polymers prevent the establishment of duck hepatitis B virus infection in vivo. Antimicrob Agents Chemother. 2013 Nov;57(11):5299-306. doi: 10.1128/AAC.01005-13. Epub 2013 Aug 12.
• Background Noordeen F, Scougall CA, Grosse A, Qiao Q, Ajilian BB, Reaiche-Miller G, Finnie J, Werner M, Broering R, Schlaak JF, Vaillant A, Jilbert AR. Therapeutic Antiviral Effect of the Nucleic Acid Polymer REP 2055 against Persistent Duck Hepatitis B Virus Infection. PLoS One. 2015 Nov 11;10(11):e0140909. doi: 10.1371/journal.pone.0140909. eCollection 2015.
• Background Jiang YF, Ma ZH, Zhao PW, Pan Y, Liu YY, Feng JY, Niu JQ. Effect of thymosin-alpha(1) on T-helper 1 cell and T-helper 2 cell cytokine synthesis in patients with hepatitis B virus e antigen-positive chronic hepatitis B. J Int Med Res. 2010;38(6):2053-62. doi: 10.1177/147323001003800620.
• Background Iino S, Toyota J, Kumada H, Kiyosawa K, Kakumu S, Sata M, Suzuki H, Martins EB. The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B; results from a randomized clinical trial. J Viral Hepat. 2005 May;12(3):300-6. doi: 10.1111/j.1365-2893.2005.00633.x.
• Background Andreone P, Cursaro C, Gramenzi A, Zavagliz C, Rezakovic I, Altomare E, Severini R, Franzone JS, Albano O, Ideo G, Bernardi M, Gasbarrini G. A randomized controlled trial of thymosin-alpha1 versus interferon alfa treatment in patients with hepatitis B e antigen antibody--and hepatitis B virus DNA--positive chronic hepatitis B. Hepatology. 1996 Oct;24(4):774-7. doi: 10.1002/hep.510240404.
• Background Zhuang L, You J, Tang BZ, Ding SY, Yan KH, Peng D, Zhang YM, Zhang L. Preliminary results of Thymosin-a1 versus interferon-alpha-treatment in patients with HBeAg negative and serum HBV DNA positive chronic hepatitis B. World J Gastroenterol. 2001 Jun;7(3):407-10. doi: 10.3748/wjg.v7.i3.407. No abstract available.
• Background You J, Zhuang L, Cheng HY, Yan SM, Yu L, Huang JH, Tang BZ, Huang ML, Ma YL, Chongsuvivatwong V, Sriplung H, Geater A, Qiao YW, Wu RX. Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: a randomized controlled study. World J Gastroenterol. 2006 Nov 7;12(41):6715-21. doi: 10.3748/wjg.v12.i41.6715.
• Usman Z, Mijocevic H, Karimzadeh H, Daumer M, Al-Mathab M, Bazinet M, Frishman D, Vaillant A, Roggendorf M. Kinetics of hepatitis B surface antigen quasispecies during REP 2139-Ca therapy in HBeAg-positive chronic HBV infection. J Viral Hepat. 2019 Dec;26(12):1454-1464. doi: 10.1111/jvh.13180. Epub 2019 Aug 13.
• Al-Mahtab M, Bazinet M, Vaillant A. Safety and Efficacy of Nucleic Acid Polymers in Monotherapy and Combined with Immunotherapy in Treatment-Naive Bangladeshi Patients with HBeAg+ Chronic Hepatitis B Infection. PLoS One. 2016 Jun 3;11(6):e0156667. doi: 10.1371/journal.pone.0156667. eCollection 2016.

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