NEW YORK, April 29, 2015 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for chronic hepatitis B and D patients, disclosed interim safety and efficacy data from its new REP 301 trial in a late breaking presentation (abstract LO2) last week at the 2015 European Association for the Study of the Liver meeting in Vienna, Austria.
The REP 301 trial, being conducted at a new European site, is examining the safety and efficacy of REP 2139-Ca monotherapy, followed by combined therapy with Pegasys® in Caucasian patients with chronic HBV / HDV co-infection. Interim data, primarily from the REP 2139-Ca monotherapy phase of the trial, has demonstrated that REP 2139-Ca was well tolerated and resulted in the rapid and simultaneous multi-log reduction of both serum HBsAg and HDV RNA. Many patients had no detectable serum HBsAg or HDV RNA after 15 weeks, before entering the combination therapy phase of the trial. The reduction or elimination of HBV and HDV viremia in the blood was accompanied by the appearance of significant titers of anti-HBsAg antibodies.
These important new clinical data validate the ability of NAPs to rapidly clear HBsAg from the blood at a second trial site and in a new ethnic patient population, demonstrating the universally reliable effect of NAPs to clear serum HBsAg in all patients. In previous Asian clinical trials, the removal of serum HBsAg by REP 2139-Ca in patients with chronic HBV allowed a significant improvement in the achievement of sustained virological response by immunotherapy compared to that normally observed with immunotherapy by itself. Future data from the REP 301 will be monitored to assess if similar outcomes occur for patients with chronic HBV / HDV co-infection.
Additionally, these new clinical data demonstrate a new therapeutic indication for NAP-based therapy, HBV / HDV co-infection, which has the potential to accelerate the approval process as an orphan indication.
Replicor’s REP 301 presentation made at EASL is available for download on the company’s website at www.replicor.com/science/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 infection. For further information about Replicor please visit our website at www.replicor.com or follow us on Twitter @replicorinc.