MONTREAL, July 12th, 2021 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the publication of the experimental biomarker analysis from its REP 401 study in Hepatology Communications.
The article, entitled “Analysis of HBsAg Immunocomplexes and cccDNA Activity During and Persisting After NAP-Based Therapy”, presents the analysis of experimental biomarkers during treatment with TDF + pegIFN + NAPs during therapy and for 48 weeks after removal of all therapy in participants with chronic HBeAg negative HBV chronic HBV infection (REP 401 study). The publication can be accessed here.
The REP 401 study (NCT02565719, previously published here) demonstrated high rates of partial (39%) and functional (39%) cure of HBV. This supplemental study, done in collaboration with Abbott Diagnostics, demonstrates that HBsAg clearance during therapy is < 0.005 IU/mL, occurs via antibody-independent mechanisms and is preserved in all participants with functional cure in the absence of HBsAg immunocomplexes. Inactivation of cccDNA occurred universally in all participants during therapy but was not correlated with the establishment of partial or functional cure. Importantly, silencing of cccDNA (undetectable HBV RNA and unquantifiable HBcrAg) was achieved and maintained during follow-up in all participants with functional cure. These results indicate the removal of HBsAg producing capacity in the liver by persistent silencing of cccDNA and removal of hepaotcytes with integrated HBV DNA.
Dr. Andrew Vaillant, CSO of Replicor commented, “This study strengthens existing data from other therapies and particularly with NAPs demonstrating the critical nature of HBsAg clearance during therapy to achieve functional cure. More importantly, integrated HBV DNA is a key source of HBsAg preventing functional cure; the strong host mediated transaminase flares we observe with NAP-based therapy appear to signal the elimination of hepatocytes with integrated HBV DNA, a critical feature of functional cure of HBV’’.
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.