Idera Pharmaceuticals (Idera) has initiated phase I clinical trial for IMO-2125 in combination with ribavirin for the treatment of naive patients with chronic hepatitis C virus (HCV) infection.
Reportedly, the phase I randomised, placebo-controlled clinical trial evaluating IMO-2125, in combination with ribavirin, is being conducted in treatment-naive patients with genotype 1 chronic HCV infection. IMO-2125 is administered subcutaneously once a week for four weeks in combination with daily oral administration of standard doses of ribavirin.
The company informed that the target enrollment for the study is 15 patients per cohort, with 12 randomised to receive IMO-2125 plus ribavirin treatment and three randomised to receive placebo plus ribavirin treatment.
The primary objective of the trial is to assess the safety and tolerability of IMO-2125 over an escalating range of dosages in combination with standard doses of ribavirin.
In addition, the effect of treatment on HCV RNA levels will be monitored. The clinical trial is expected to be conducted at five or more sites in France and Russia.
Tim Sullivan, VP of development programs at Idera, said: ”We expect that the IMO-2125 trial with ribavirin in treatment-naive HCV patients and our ongoing IMO-2125 monotherapy trial in HCV patients who failed to respond to previous standard of care therapy will provide us with data in two HCV patient populations on safety, immunological activity, and effect on HCV RNA levels. We plan to use the data from these ongoing trials to guide us in further clinical development of IMO-2125 in the treatment of chronic HCV infection.”