MONTREAL, June 1st 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 Science of HBV Cure Conference held May 30 – June 2, 2022 in Singapore (see here).
Replicor’s expanded use program currently focuses on cirrhotic patients with chronic HBV / HDV co-infection in Romania (1 patient) and in 3 patients in France who failed to respond to bulvertide combination therapy. REP 2139-Mg is being used as a weekly subcutaneous injection in addition to TDF and low dose (90µg) pegIFN therapy in all patients in France. 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. Two patients have completed therapy (one in Romania and one in France). In both these patients, early host mediated transaminase flares were asymptomatic and accompanied by rapid decline and clearance of both HDV RNA and HBsAg (with seroconversion). Following removal of NAPs and pegIFN (with maintained TDF therapy), HBsAg and HDV RNA remain undetectable at 3 and 1 month(s) respectively, with normal liver function.
Two additional patients are early in their combination therapy and are experiencing antiviral responses. Of these patients, one has cleared HDV RNA at week 4 with a 4.22 log10 IU/mL reduction in HBsAg at week 8.
Dr. Vaillant commented, “our expanding compassionate use program is designed to offer REP 2139-Mg to those with urgent medical need who do not have other treatment options. Our evolving clinical experience with these patients will expand the safety and efficacy envelope of subcutaneously administered REP 2139-Mg as part of combination therapy and of associated host mediated transaminase flares in those patients with advanced liver disease”.
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.