MONTREAL, May 1st, 2023 – Replicor Inc., presented updated clinical data in HBV and HDV infection in three oral presentations at the 2023 Global Hepatitis Summit held April 24th – 28th in Paris France (see here).
In a late breaking oral presentation, Dr. Andrew Vaillant, CSO of Replicor Inc. presented new follow-up data from the previous REP 301 (HBV / HDV) and REP 401 (HBV) studies, extending treatment-free follow-up to 7.4 and 5.3 years respectively. In the REP 301 study, functional cure of HDV (undetectable HDV RNA with normal liver function) and functional and partial cure of HBV were preserved. In the REP 401 study, HBV functional cure and partial cure were also preserved, with a net increase in functional cure, suggesting functional cure rates as high as 56%. No evidence of liver toxicity or HCC was observed, and liver stiffness continued to decline or became normal in most patients in both studies.
Dr. Christiane Stern (Hôpital Beaujon, Clichy, France), presented updated data on the safety and tolerability of TDF + REP 2139-Mg in three patients with HBV / HDV decompensated cirrhosis, demonstrating continued safety and good tolerability with antiviral responses (including HDV RNA and HBsAg loss / anti-HBsAg seroconversion and ALT normalization during therapy).
Dr. Marc Bourlière (Hôpital Saint Joseph, Marseille, France) presented updated data on the expanding French cohort of bulevirtide failure patients with compensated cirrhosis receiving TDF + REP 2139-Mg + 90µg pegIFN. In this cohort of patients, HBV RNA and HBsAg responses (including HDV RNA and HBsAg loss, HBsAg seroconversion and ALT normalization) continued to be accompanied by a good safety profile. After completing REP 2139-Mg + pegIFN, two patients have maintained persistent HDV RNA / HBsAg loss, Anti-HBs seroconversion and normal liver function. In one of these patients TDF has now been removed (after 10 months) with all antiviral responses continuing to be maintained for two months.
While ALT flares are frequent during NAP therapy in non-cirrhotic patients, only one ALT flare has been observed in these cirrhotic patients to date, suggesting that ALT flares observed during REP 2139-Mg therapy are related to immunological differences between cirrhotic and non-cirrhotic livers and not to REP 2139-Mg exposure.
Dr. Vaillant commented, “The assistance of Dr. Bourlière, Dr. Stern and the community of French investigators involved in the compassionate use of REP 2139-Mg in these special HBV / HDV patient populations in France is instrumental in expanding the safety envelope of and treatment indications for REP 2139-Mg.We continue to be encouraged by the excellent safety profile and antiviral activity in compensated and decompensated cirrhosis as well as the long-term safety and highly durable nature of functional cure of HBV and HDV from our previous phase II studies with REP 2139.”
These presentations can be accessed at http://replicor.com/conference-presentations/.
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.