Idera Pharmaceuticals today announced that it had completed patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 trial of IMO-3100 in patients with moderate-to-severe plaque psoriasis. IMO-3100 is an antagonist of specific Toll-like Receptors (TLRs) that the Company is developing for the treatment of psoriasis and other autoimmune diseases. Idera anticipates top-line data from this study will be available by year-end 2012. TLRs are a class of proteins that play a key role in both inflammation and immunity. Through the inhibition of specific TLRs, Idera's candidates may represent a novel approach for the treatment of psoriasis, lupus and other autoimmune diseases.
“We have made significant progress in advancing our autoimmune disease program, including the completion of enrollment in the Phase 2 trial of IMO-3100 in patients with psoriasis.”
"In this Phase 2 proof-of-concept study, we are evaluating multiple endpoints to assess the clinical activity of IMO-3100, including the impact on Psoriasis Area Severity Index (PASI), mean focal psoriasis severity, and Physician Global Assessment (PGA) scores," said Dr. Robert Arbeit, Vice President of Clinical Development at Idera. "In addition to the clinical assessments, we are evaluating biopsies of psoriasis plaques for treatment-related changes in epidermal thickness and immune cell infiltrates consistent with the intended mechanism of action."
"We have made significant progress in advancing our autoimmune disease program, including the completion of enrollment in the Phase 2 trial of IMO-3100 in patients with psoriasis." said Dr. Sudhir Agrawal, Chief Executive Officer of Idera. "In addition, our investigational new drug (IND) application for IMO-8400, a lead candidate for lupus, is now active. We expect our phase 2 study of IMO-3100 and planned clinical trials of IMO-8400 will help us to establish the benefits of inhibiting Toll-like Receptor-mediated pathways, which include controlling the induction of multiple cytokines, such as TNF-α, IL-12, IL-6, and IL-17, as well as downstream signaling. We look forward to reporting top-line data from the Phase 2 study of IMO-3100 in psoriasis and initiating clinical development of IMO-8400 before the end of 2012."
Idera also announced today that its Investigational New Drug application for IMO-8400 with the US Food and Drug Administration is now active. IMO-8400, an antagonist of TLRs 7, 8, and 9, is Idera's second lead candidate for use in treating autoimmune diseases, with lupus selected as an initial indication for clinical development. Idera anticipates initiating a Phase 1 dose escalation trial during the fourth quarter of 2012 to evaluate the safety and pharmacodynamics of IMO-8400 in healthy subjects. Following successful completion of the Phase 1 study, Idera expects to initiate a Phase 2 clinical trial of IMO-8400 in patients with lupus.
Recent and Upcoming Autoimmune Disease Program Milestones
Fourth Quarter 2012:
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Complete enrollment in Phase 2 trial of IMO-3100 for the treatment of moderate to severe plaque psoriasis (completed)
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Submission of Investigational New Drug (IND) application to the US Food and Drug Administration for IMO-8400 (completed)
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Present preclinical data on IMO-8400 at major scientific meetings
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Initiation of Phase 1 trial of IMO-8400
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Report top-line data from the Phase 2 trial of IMO-3100 for the treatment of moderate-to-severe plaque psoriasis
Year 2013:
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Report final data from the Phase 2 trial of IMO-3100 for the treatment of moderate-to-severe plaque psoriasis
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Report data from Phase 1 trial of IMO-8400
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Initiate Phase 2 trial of IMO-8400 in patients with lupus
Cardiovascular disease pathways associated with psoriasis, but not other immune-mediated diseases