MONTREAL, September 22nd 2022 – Replicor Inc., presented updated clinical data from its expanded compassionate use program for treating chronic HBV/HDV co-infection in cirrhotic patients at the 2022 International HBV Meeting held September 18 – 21, 2022 in Paris (see here).
Replicor’s expanded use program in France now includes 5 patients with advanced HBV/HDV co-infection, 4 with compensated cirrhosis who failed on bulevirtide therapy and a fifth with decompensated cirrhosis. Dr. Andrew Vaillant (CSO of Replicor) presented updates on the progress of therapy in these patients (see here).
Weekly subcutaneous therapy of REP 2139-Mg with TDF + pegIFN has been well tolerated in all patients to date. One patient has completed therapy and maintains undetectable HBsAg and HDV RNA with increasing anti-HBsAg titers and normal liver function for two months after removing REP 2139-Mg and pegIFN therapy.
Strong HDV RNA and HBsAg declines are occurring in the other 3 patients with compensated cirrhosis, with two achieving HBsAg and HDV RNA elimination to undetectable levels early in therapy.
REP 2139-Mg + TDF has been well tolerated in the patient with decompensated cirrhosis with HBsAg loss and decline in HDV RNA already achieved. Initial significant ascites in this patient rapidly reversed within 4 weeks and is stable in the absence of diuretics.
Dr. Vaillant commented, “we continue to expand our compassionate use program in France and other countries and now in patients with very advanced liver disease to offer REP 2139-Mg for critical cases of HBV/HDV co-infection. This invaluable clinical experience will pave the way for future phase II trials featuring subcutaneously administered REP 2139-Mg and expanded inclusion criteria including cirrhotic participants”.
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