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IMO-3100, an antagonist of TLR7 and TLR9, is a lead drug candidate in development to treat autoimmune diseases. IMO-3100 is designed to block production of multiple pro-inflammatory cytokines induced through TLR7 and TLR9. IMO-3100 has demonstrated potent activity in reducing pathologic and immunologic manifestations in preclinical mouse models of diseases such as lupus (Presentation), rheumatoid arthritis (Presentation), psoriasis (Presentation) and hyperlipidemia (Presentation).
Clinical Trials of IMO-3100
IMO-3100 Phase 1 Single-Ascending Dose Clinical Trial in Healthy Subjects
Idera has completed two Phase 1 clinical trials of IMO-3100 to evaluate the safety and mechanism of action. The first Phase 1 study was a single-dose, dose escalation study involving 36 healthy subjects. (Press Release) (Presentation)
IMO-3100 Phase 1 Multiple-Ascending Dose Clinical Trial in Healthy Subjects
The second Phase 1 study was a four-week placebo-controlled multiple-dose clinical trial of IMO-3100 in 24 healthy subjects using two treatment regimens. (Press Release) (Presentation)
In these trials, IMO-3100 was administered by subcutaneous injection. The primary objective was evaluation of safety and tolerability. Secondary objectives were to characterize the pharmacokinetics of IMO-3100 and to assess the pharmacodynamic mechanism of action in peripheral blood mononuclear cells (PBMCs).
Next Steps in Clinical Development of IMO-3100
Idera plans for the next step in clinical development of IMO-3100 to be a Phase 2 clinical trial in a selected autoimmune disease indication. Idera expects to initiate the first Phase 2 clinical trial of IMO-3100 in the second half of 2011.
The Company has established an Autoimmune Disease Scientific Advisory Board to assist the Company with the clinical development strategy for IMO-3100.
Data from Idera's research with IMO-3100 and other TLR antagonists have been presented at various scientific meetings:
Presentations
- Treatment with IMO-3100, a Novel TLR7 and TLR9 Dual Antagonist, Inhibits Disease Development in a Mouse Model of Collagen Antibody-induced Arthritis (CAIA), Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS), June 2011
(Press Release) (Presentation)
- A Novel Toll-like Receptor Antagonist for Autoimmune and Inflammatory Diseases: Safety and Pharmacodynamics in a Multiple-Dose Phase 1 Clinical Trial, Keystone Symposia Meeting: Immunoregulatory Networks, April 2011
(Presentation)
- Treatment with IMO-3100, a Novel TLR7 and TLR9 Antagonist, Inhibits Disease Development in Lupus Prone NZBW/F1 Mice, Keystone Symposia: Dendritic Cells and the Initiation of Adaptive Immunity, February 2011
(Press Release)(Presentation)
- IMO-3100, a Toll-like receptor (TLR) Antagonist, Suppresses TLR7- and TLR9-mediated Immune Responses in Non-Human Primates, 74th Annual Scientific Meeting of the American College of Rheumatology, November 2010
(Press Release)(Presentation)
- Peripheral Blood Mononuclear Cells and Plasmacytoid Dendritic Cells from Healthy Human Females Exhibit Altered TLR7-Mediated Immune Responses Compared to Males, 74th Annual Scientific Meeting of the American College of Rheumatology, November 2010
(Press Release)(Presentation)
- Safety and Pharmacodynamics of IMO-3100, a Novel Toll-like Receptor Antagonist for Autoimmune and Inflammatory Diseases, in a Rising Single-Dose Phase 1 Clinical Trial, 6th Annual Meeting of the Oligonucleotide Therapeutics Society, October 2010
(Presentation)
- IMO-3100, a Novel Antagonist, Suppresses TLR7- and TLR9-Mediated Immune Responses in Non-Human Primates, Keystone Symposia conference "Tolerance and Autoimmunity", February 2010
(Press Release)(Presentation)
- Studies of Combination of IMO-3100, An Antagonist of TLR7 and TLR9, and Etanercept, a TNF-alpha Inhibitor, in a Mouse Model of Collagen-Induced Arthritis (CIA), Annual Scientific Meeting of the American College of Rheumatology and Association of Rheumatology Health Professionals, October 2009
(Press Release)(Presentation)
- Synthetic DNA-Based Antagonist of TLR7 and 9 Protects Mice Against TNBS-Induced Colitis, Oligonucleotide Therapeutics Society, October 2008
(Press Release)(Presentation)
- Evaluation of a DNA-Based Toll-like Receptor Antagonist for Treatment of Collagen-Induced Arthritis in DBA/1 Mice, Oligonucleotide Therapeutics Society, October 2008
(Press Release)(Presentation)
- A Toll-like Receptor Antagonist Prevents Development of IL-23-induced Psoriasis-like Dermal Changes in Mice, FOCIS, June 2008
(Press Release)(Presentation)
- Studies of Oligonucleotide-Based Antagonists of TLR9 in a Mouse Model of Experimental Autoimmune Encephalomyelitis, American Academy of Neurology, April 2008
(Press Release)(Presentation)
- Novel Class of DNA-Based Compounds Act as Antagonists for TLR7 and 9: In Vitro and In Vivo Studies in MRL-lpr and NZBW/F1 Mouse Models, Keystone Symposia, February 2007
(Press Release)(Presentation)
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