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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.
“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.”