Idera starts Phase I trial for hepatitis C drug

IMO-2125 is a novel agonist of toll-like receptor 9. The trial is designed to assess the safety and tolerability of IMO-2125 at different dose levels as well as determine the effect of IMO-2125 on HCV RNA levels and parameters of immune system activation.

Sudhir Agrawal, CEO and CSO, said: “IMO-2125 is a TLR9 agonist that Idera designed to induce endogenous interferon-alpha along with other immune response factors to treat hepatitis C. IMO-2125 is the second novel TLR9 agonist from our portfolio to enter the clinic following IMO-2055 for cancer.

“We generated both of these drug candidates using our chemistry-based drug discovery approach which allows us to design TLRtargeted drug candidates which act as agonists for TLR7, 8 or 9 or as TLR antagonists for a broad spectrum of indications.”

Robert Karr, president, said: “The preclinical data that we have generated, including data demonstrating potency in the HCV replicon assay of cytokines and chemokines present in the blood of non-human primates treated with IMO-2125, provides a strong rationale for evaluating IMO-2125 in patients with HCV infection.”

The Phase I trial evaluating IMO-2125 is being conducted in HCV patients who have failed to respond to previous combination therapy with ribavirin and pegylated interferon-alpha. Four doses of IMO-2125 are being investigated. IMO-2125 will be administered subcutaneously once a week and treatment will continue for four weeks. The target enrollment for the trial is 40 patients with ten patients per cohort. Of the ten patients per cohort, eight are randomized to receive IMO-2125 treatment and two are randomized to receive placebo treatment.