Replicor presents updated clinical efficacy results in patients with chronic hepatitis B with short term exposure to immunotherapy in combination with REP 2139-ca and new clinical data in patients receiving this combination treatment while currently on entecavir (triple combination therapy).
26 April 2013, Amsterdam, Netherlands.
April 26th, 2013 – Replicor is currently undertaking a proof of concept trial in patients with chronic hepatitis B (HBV) undergoing treatment with its nucleic acid polymer (NAP) REP 2139-ca in combination with Zadaxin™ or Pegasys™.
Updated interim results from this ongoing proof of concept trial as well as new interim results from new patients that are receiving combination therapy with Pegasys™ and REP 2139-ca at the start treatment while continuing previous entecavir therapy were disclosed on April 26th, 2013 at the 49th annual meeting of the European Association for the Study of the Liver (EASL) held in Amsterdam, the Netherlands.
Patients who had cleared HBsAg from their blood with REP 2139-ca monotherapy were subjected to combination treatment with REP 2139-ca and either Pegasys™ or Zadaxin™. Profound increases in anti-HBV antibodies or immune function were observed in all patients with as few as 6-10 weeks of combination treatment. All patients have achieved HBV antibody levels seen in healthy patients after vaccination with a total of 12 weeks of combination treatment and many patients have achieved antibody titers > 1000 mIU / ml. In 8 out of 9 patients who have achieved this therapeutic vaccine-like response, they continue to control their viral infection 12 – 24 weeks after all treatment is stopped.
In three new patients who received combination treatment (REP 2139-ca/ Pegasys™) at the start of therapy (two patients also continued previous entecavir therapy), treatment was well tolerated and the clearance of serum HBsAg and appearance of robust levels of anti-HBs comparable to those observed in the previous trial was achieved more rapidly (within 5 weeks and 9 weeks respectively) than in the previous trial where patients started immunotherapy only after clearance of serum HBsAg. Replicor expects that initiation of combination therapy with REP 2139-ca and immunotherapeutic agents at the start of treatment can dramatically accelerate the restoration of the immune response and this combination treatment appears to be well tolerated in the presence of on-going entecavir therapy.
For the 49th annual EASL meeting: