MONTREAL, February 15th, 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 analysis of the clinical benefit of transaminase flares in its REP 401 study in the Journal of Viral Hepatitis. Hepatology Communications.
The article, entitled “Benefit of transaminase elevations in establishing functional cure of HBV infection during NAP‐based combination therapy”, presents the analysis of correlations between liver enzyme elevations and HBsAg clearance during NAP-based combination therapy and the establishment of functional cure of HBV and can be accessed here.
Asymptomatic elevations in liver enzymes (“flares” of ALT, AST and GGT) during therapy of HBV infection result from the targeting of infected cells in the liver by the immune response. These flares are commonly associated with positive outcomes (i.e. functional cure) with currently approved therapies but only occur very infrequently. Asymptomatic liver enzyme flares are highly prevalent with NAPs, allowing a better examination of the roles these flares play in achieving functional cure. In the REP 401 study, productive flares (followed by functional cure) could be differentiated from non-productive flares (followed by viral rebound during follow up) by the absence of HBsAg during productive flares.
Dr. Andrew Vaillant, CSO of Replicor commented, “This flare analysis is the latest clinical data showing that NAP-based combination therapy not only dramatically increases the frequency of therapeutic liver enzyme flares compared to other therapies approved or in development but more importantly, that these flares being accompanied by HBsAg clearance signal the restoration of the ability of the immune response to effectively target both cccDNA and integrated HBV DNA in the liver. This effective restoration of immune function capable of targeting HBV infection in the liver is the likely basis for the high rates of functional cure uniquely achieved by NAPs.”
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.