Replicor Inc., a privately held biopharmaceutical company targeting a cure for patients with chronic hepatitis B virus (HBV) and chronic HBV and hepatitis delta virus (HDV) co-infection, disclosed updated interim safety and efficacy data from its ongoing REP 301 trial (NCT02233075) at the 2015 meeting of the American Association for the Study of Liver Disease (AASLD) being held from November 13-17 in San Francisco, USA. The REP 301 trial update was presented (Abstract 31) on Sunday November 15th in Parallel Session 4: Hepatitis B: Novel Treatments and Treatment Targets.
Previously reported HBsAg reductions with REP 2139-Ca monotherapy continued to improve during combination therapy with pegylated interferon alpha-2a, becoming > 6 logs in 4 patients (0.01 IU / ml), > 5 logs in 2 patients, > 3 logs in 2 patients and 0.5-2.78 logs in the remaining 4 patients. HDV RNA continued to decline in all patients and is now currently undetectable in ten patients (~5-8 log reduction from baseline). Importantly, the addition of pegylated interferon alpha-2a to therapy was associated with dramatic increases in free anti-HBs (to levels as high as 20,665 mIU / ml) and liver flares, but only in those patients who achieved serum HBsAg < 1 IU / ml (> 4 log reduction from baseline) at the start of immunotherapy. These results continue to demonstrate the clinical potential of REP 2139-Ca in HBV / HDV co-infection and begin to shed light on the importance of achieving multilog reductions in serum HBsAg to improve the antiviral effect of immunotherapy.
A copy of the presentation made will be made available at http://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.
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