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IMO-2125, a TLR9 agonist, is in clinical development for the treatment of chronic hepatitis C virus (HCV) infection.
IMO-2125 was created by Idera through its chemistry-based approach to making TLR-targeted compounds. IMO-2125 has been shown to induce production of high levels of interferon-alpha and other immune system proteins in preclinical models, both in vitro and in vivo. IMO-2125 induces interferon-alpha and immune system proteins that show activity in HCV replicon cell-based assays. [Press Release]
Ongoing Clinical Trials
At present, Idera is evaluating IMO-2125 in two ongoing clinical trials in two different HCV patient populations:
IMO-2125 Phase 1 Clinical Trial in Non-responder Patients with HCV
Idera is conducting a Phase 1 clinical trial of IMO-2125 in patients with chronic HCV infection who are null responders to the current standard of care treatment. Null responders are defined as patients who have failed to achieve a 2 log10 reduction in viral load during previous 12 to 24 weeks of treatment with pegylated recombinant interferon-alpha plus ribavirin. The primary objective of the trial is to assess the safety of IMO-2125 over an escalating range of dose levels and to determine the effect of IMO-2125 on HCV RNA levels. The target enrollment is ten patients per cohort, with eight randomized to receive IMO-2125 treatment and two randomized to receive placebo treatment. Four dose levels of IMO-2125 have been investigated, with subcutaneous administration once per week for four weeks. Interim results showed that all four dose levels of IMO-2125 were well tolerated for the four weeks of treatment. Additionally, IMO-2125-treated patients showed dose-dependent increases in endogenous interferon-alpha, interferon-inducible protein 10 (IP-10), and 2’,5’-oligoadenylate synthetase (2’,5’-OAS) concentrations. Forty to 75% of patients receiving 0.08 to 0.32 mg/kg IMO-2125 achieved reduction in viral load of > 1 log10 at least once during the treatment period. None of the patients who received placebo or 0.04 mg/kg IMO-2125 showed reduction in viral load of > 1 log10 at any time during the treatment period. Based on these data, the trial has been extended to a fifth dose level and patients are being recruited. The trial is being conducted at six U.S. sites. [Press Release].
IMO-2125 Phase 1 Clinical Trial with Ribavirin in Treatment-naïve Patients with HCV
Idera is also conducting a Phase 1 clinical trial of IMO-2125 in combination with ribavirin in patients with chronic HCV infection who are naïve to treatment with standard of care. The primary objective of the trial is to assess the safety of IMO-2125 over an escalating range of dosages in combination with standard doses of ribavirin and to determine the effect of treatment on HCV RNA levels. The target enrollment is 15 patients per cohort, with 12 randomized to receive IMO-2125 plus ribavirin treatment and three randomized to receive placebo plus ribavirin treatment. IMO-2125 will be administered subcutaneously once per week and ribavirin will be administered orally every day for four weeks. The trial is being conducted at five or more sites in France and Russia. [Press Release]
Idera has formed a Hepatitis C Clinical Advisory Board composed of distinguished members of the global infectious disease community that advises Idera on the development of IMO-2125 for HCV.
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