MONTREAL, February 20th, 2023 – Replicor Inc., presented updated clinical data in HBV and HDV infection in a greatly expanded cohort of patients receiving compassionate access to REP 2139-Mg at the 2023 annual meeting of the Asia Pacific Association for the Study of the Liver (APASL) held February 15th – 19th, 2023 in Taipei, Taiwan (see here).
The Replicor Compassionate Access Program (RCAP, NCT05683548) provides REP 2139-Mg for patients with HBV or HBV / HDV infection who do not respond to current therapies with compensated or decompensated cirrhosis. This compassionate access program now includes 26 patients from France, Israel, Austria, Italy, Turkey and Australia. In France, 16 patients are now receiving therapy in 8 centers. Dr. Andrew Vaillant, CSO of Replicor, presented updates on the progress of therapy in the 10 French patients with > 4 weeks of exposure in two presentations (see here).
Weekly subcutaneous therapy of REP 2139-Mg with TDF + pegIFN continues to be easily tolerated with many patients performing self-injection on an outpatient basis. REP 2139-Mg therapy has been safe with no systemic adverse events, even in patients with decompensated cirrhosis. Rapid ALT normalization and reversal of ascites within 4-6 weeks is universally observed and precedes antiviral response.
Antiviral responses with REP 2139-Mg appear to be stronger with SC administration than in previous clinical trials which used IV infusion.
One patient has completed therapy and has maintained undetectable HBsAg and HDV RNA with HBsAg seroconversion for 8 months and has now been removed from supportive TDF therapy.
Strong HDV RNA and HBsAg declines / loss and anti-HBs seroconversion are occurring in all patients with > 12 weeks of therapy.
Dr. Vaillant commented, “These data continue to support our expectations of improved performance of REP 2139-Mg with subcutaneous injection in future phase II trials versus the already excellent performance of IV infusion in previous studies. We are greatly encouraged by the obvious hepatoprotective effects of REP 2139-Mg and excellent safety profile in compensated and decompensated cirrhosis. These results promise to expand access to REP 2139-Mg for all patients with HBV infection, regardless of co-infection or the severity of 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.