IMO-2125, a TLR9 agonist, is a novel immune modulator being developed as a potential alternative to recombinant interferon for the treatment of chronic HCV-infected patients. 

Clinical Trials of IMO-2125

Idera has completed four-week Phase 1 clinical trials of IMO-2125 as monotherapy in null-responder HCV patients and in combination with ribavirin in treatment-naïve HCV patients.

IMO-2125 Phase 1 Clinical Trial in Null-responder Patients with HCV

This trial enrolled cohorts of ten patients at five escalating IMO-2125 dose levels. Patients in each cohort received IMO-2125 monotherapy or placebo once per week by subcutaneous injection for four weeks. The primary objective of the trial was to assess the safety of IMO-2125 at each dose level. The trial also evaluated the effects of IMO-2125 on HCV RNA levels and on immune system activation.

During 2010, Idera presented data from this study at the 45th Annual Meeting of the European Association for the Study of the Liver (Press Release) (Presentation) and at the 61^st Annual Meeting of the American Association for the Study of Liver Diseases. (Press Release) (Presentation)

IMO-2125 Phase 1 Clinical Trial in Treatment-naïve Patients with HCV

This clinical trial evaluated IMO-2125 at multiple dose levels using both once-weekly and twice-weekly dosing regimens for four weeks in combination with ribavirin. Control patients received pegylated recombinant interferon-alpha and ribavirin for four weeks. The primary objective of the trial was to assess the safety and tolerability of IMO-2125 in combination with ribavirin. In addition, Idera monitored the effect of treatment on HCV RNA levels.

Idera presented data from this study at the 46^th Annual Meeting of the European Association for the Study of the Liver. (Press Release) (Presentation)

Next Steps in Clinical Development of IMO-2125

Idera has planned a 12-week Phase 2 clinical trial of IMO-2125 in combination with ribavirin in treatment–naïve HCV patients. Initiation of this planned clinical trial is pending evaluation of data from chronic nonclinical toxicology studies of IMO-2125, which Idera expects to be available in the second half of 2011.  (Press Release)

The Company has established a Hepatitis C Scientific Advisory Board to assist the Company with the clinical development strategy for IMO-2125.

Data from Idera's research with IMO-2125 have been presented at various scientific meetings:

Presentations

• IMO-2125 plus ribavirin gives substantial first-dose viral load reductions, cumulative anti-viral effect, is well tolerated in naive genotype 1 HCV patients: a Phase 1 trial. 46^th Annual Meeting of the European Association for the Study of the Liver, 2011
  (Presentation)
  
  
• IMO-2125, a TLR9 Agonist, Induces Immune Responses which Correlate with Reductions in Viral Load in Null-Responder HCV Patients.. 61st Annual Meeting of the American Association for the Study of Liver Diseases, 2010
  (Presentation)
  
  
• A Phase 1, Multi-Center, Randomized, Placebo-controlled, Dose-escalation Study of IMO-2125, a TLR9 Agonist, in Hepatitis C Nonresponders. 45th Annual Meeting of the European Association for the Study of the Liver, 2010
  (Presentation)
  
  
• IMO-2125, an Agonist of TLR9 that Induces Endogenous IFN-α, Upregulates Broader Range of Gene Expression Profiles Compared to Exogenously Added IFN-α in Human PBMC. 45th Annual Meeting of the European Association for the Study of the Liver, 2010
  (Press Release) (Presentation)
  
  
• IMO-2125, a TLR9 Agonist, Induces Th-1 Type Cytokines and Interferons with Potent Anti-HCV Activity in Human Peripheral Blood Mononuclear Cells (PBMCs) and Plasmacytoid Dendritic Cells (pDCs). 60th Annual Meeting of the American Association for the Study of Liver Diseases; Abstract number 1593, 2009
  (Press Release) (Presentation)
  
  
• Gene Expression Profiles Induced by IMO-2125, an Agonist of Toll-like Receptor 9, in Human Peripheral Blood Mononuclear Cells. 60th Annual Meeting of the American Association for the Study of Liver Diseases; Abstract number 1597, 2009
  (Press Release) (Presentation)
  
  
• IMO-2125, a TLR9 Agonist that Induces High Interferon-(alpha) Production, as a Candidate for Hepatitis C Therapy. 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); Abstract number 1583, 2007
  (Press Release) (Presentation)