Infectious Diseases
Hepatitis C Virus (HCV)
Currently, the standard of care for treating chronic HCV infection is administration of a single recombinant interferon alpha protein, in combination with ribavirin. Natural interferon is produced by the body as part of an immune response. Certain agonists of TLRs stimulate an innate immune response with the production of various cytokines, including interferon-alpha, which are important signaling molecules for the immune system. The immune responses induced by TLRs also lead to development of adaptive immune responses, due to activation of antigen-presenting cells and generation of sensitized immune cells. Because of the activity generated by natural interferon-alpha and other cytokines induced through TLRs, Idera believes that TLR agonists could provide potential advantages over recombinant interferons for the treatment of chronic HCV infection.
Through our structure-activity relationship studies, we have identified IMO-2125, a TLR9 agonist which has been shown to induce high levels of interferon-alpha and other cytokines in preclinical models. IMO-2125 has been selected as a lead candidate for the treatment of chronic HCV infection.
IMO-2125
IMO-2125 is designed to act as an agonist of TLR9. In preclinical studies using human cell-based assays, IMO-2125 has been shown to induce high levels of natural interferon-alpha and other cytokines. In non-human primates, subcutaneous administration of IMO-2125 has been shown to increase plasma concentrations of interferon-alpha and other cytokines and to activate lymphocytes and other white blood cells.
In May 2007, we submitted an IND to the U.S. Food and Drug Administration for IMO-2125. In September 2007, we initiated a Phase 1 trial of IMO-2125 in patients with HCV who have not responded to standard recombinant interferon therapy in conjunction with ribavirin.
Idera has formed a Hepatitis C Clinical Advisory Board composed of distinguished members of the global infectious disease community that advises the Company on the development of IMO-2125 for HCV.
