Replicor publishes its REP 301-LTF study achieving durable functional cure of HDV and HBV, inactivation of cccDNA and elimination of integrated HBV DNA

Replicor publishes its REP 301-LTF study achieving durable functional cure of HDV and HBV, inactivation of cccDNA and elimination of integrated HBV DNA

Below, we are re-publishing with permission the press-release issued by Replicor Inc. on November 16, 2020

MONTREAL, November 16th, 2020 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the publication of the final results of the long term follow-up of its REP 301 study (REP 301-LTF study) in Hepatology Communications.

The article, entitled “Persistent control of HBV and HDV infection following REP 2139-Ca and pegIFN therapy in chronic HBV/HDV co-infection”, presents the analysis of 3.5 years of follow-up on the safety and efficacy of a suboptimal regimen of REP 2139 and pegIFN in chronic HBV / HDV co-infection and can be accessed here.

Included for the first time in this publication is analysis of experimental markers of HBV infection from an ongoing collaboration with Abbott Diagnostics, demonstrating that HBsAg reduction to < 0.005 IU/mL during therapy does not appear driven by antibody mediated clearance.  Importantly, the persistence of undetectable HDV RNA, normal liver function with improving fibrosis status continues for 3.5 years after removal of all therapy.  Many of these patients also maintain functional cure of HBV with no detectable HBV pgRNA and HBcrAg < LLOQ.  Importantly, in participants with functional cure of HBV, HBsAg was maintained < 0.005 IU/mL in the absence of antibody mediated HBsAg clearance, indicating the loss of HBsAg producing capacity in the liver and removal of integrated HBV DNA.  

Dr. Andrew Vaillant, CSO of Replicor commented, “Our clinical experience with NAPs highlights their unique ability to achieve long term durable control of both HDV and HBV infection, restoration of normal liver function and progressive reversal of liver inflammation and fibrosis.  We are very excited by the new experimental marker data indicating the efficient inactivation of cccDNA and removal of integrated HBV DNA, the latter likely signaled by the strong host mediated transaminase flares observed during and common with profound HBsAg reduction unique to NAP therapy.  These new observations suggest that very long-term control of both HBV and HDV infection are achieved with NAP-based therapy.  We look forward to evaluating the optimized NAP-based combination therapy used in the REP 401 study in co-infected subjects, which promises much higher rates of functional cure of HDV and HBV’’.

About Replicor 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.

* The study is conducted by Clinical Accelerator

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