Autoimmune: IMO-3100

IMO-3100, an antagonist of TLR7 and TLR9, is in clinical development to treat autoimmune and inflammatory diseases.

A hallmark of many autoimmune and inflammatory diseases is the production of multiple pro-inflammatory cytokines induced through TLR7 and TLR9, which IMO-3100 is designed to block. 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).

Idera has completed two Phase 1 clinical trials of IMO-3100 in healthy subjects to evaluate the safety and mechanism of action. 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.

The next step in clinical development of IMO-3100 is a clinical proof-of-concept study in patients with psoriasis. As announced in December 2011, Idera has received FDA’s notification to proceed with a Phase 2 trial of IMO-3100 in psoriasis. (Press release)

Clinical Trials of IMO-3100

IMO-3100 Phase 1 Single-Ascending Dose Clinical Trial in Healthy Subjects

The first Phase 1 study was a single-dose, dose escalation study involving 36 healthy subjects. (Press Release) (Presentation)

IMO-3100 Phase 1 Multiple 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)