MONTREAL, March 9, 2020 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced the publication of the final results of its latest REP 401 study in the prestigious journal Gastroenterology.
The article, entitled “Safety and Efficacy of 48 Weeks REP 2139 or REP 2165, Tenofovir Disoproxil, and Pegylated Interferon Alfa-2a in Patients With Chronic HBV Infection Naïve to Nucleos(t)ide Therapy”, presents the analysis of the safety and efficacy of NAP therapy when added to a backbone of TDF and pegIFN in patients with treatment naïve chronic HBV infection.
The culmination of more than a decade of clinical investigation of NAPs, transitioning from REP 2055 to REP 2139-Mg, the REP 401 study achieved dramatic increases in the incidence of HBsAg loss and seroconversion during therapy (60%) and therapeutic transaminase flares (95%) compared to that observed with TDF + pegIFN alone. Importantly 78% of participants achieved virologic control of HBV of whom 39% further achieved functional cure. These outcomes dramatically improve those achieved by TDF + pegIFN alone and far exceed those observed with any other therapy currently in development in mono or combination therapy.
r. Andrew Vaillant, CSO of Replicor commented, “Our substantial body of published data clearly demonstrates that all NAPs using Replicor’s proprietary poly AC technology have very similar activity with similar doses required in humans. However, only NAPs formulated as magnesium chelate complexes such as REP 2139-Mg and REP 2165-Mg have the excellent tolerability and safety required for use with immunotherapy. This combination approach is essential to awaken an effective immune response capable of driving high rates of therapeutic transaminase flares essential for restoring virologic control and functional cure. The successful completion of the REP 401 study paves the way for the long-planned transition of REP 2139-Mg to subcutaneous administration and assessment in combination with other immunotherapies capable of driving HBsAg specific T-cell activation, an activity we believe is a critical component of achieving functional cure.”
The article can be accessed directly at the following link:
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 http://www.replicor.com.
* The study is conducted by Clinical Accelerator