Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the treatment of the first patient in a Phase 2 clinical trial of IMO-3100, the Company’s lead Toll-like receptor (TLR) inhibitor for the treatment of autoimmune diseases, in patients with moderate to severe plaque psoriasis.
“With the initiation of a Phase 2 trial for IMO-3100 in psoriasis, we have achieved another important milestone by having mid-stage clinical trials underway for proprietary drug candidates targeting TLRs in both oncology and autoimmune diseases, our two key therapeutic areas of focus,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. "We expect our clinical pipeline in autoimmune diseases will expand further with the advancement of IMO-8400 for the treatment of lupus following the anticipated submission of an investigational new drug (IND) application with the U.S. Food and Drug Administration during the fourth quarter of 2012. We look forward to achieving additional near-term milestones, including the completion of a Phase 2 study for IMO-2055 in head and neck cancer expected during the second quarter of 2012 and completion of the Phase 2 study for IMO-3100 in psoriasis expected during the first half of 2013.”
IMO-3100 is an immunomodulator that inhibits the activity of TLR7 and TLR9 and modulates the production of multiple pro-inflammatory mediators, including TNF-α, INF-α, IL1-β, IP-10, IL-17, and IL-23. IMO-3100 has demonstrated potent activity in reducing pathologic and immunologic manifestations in preclinical mouse models of psoriasis. In Phase 1 studies in healthy subjects, IMO-3100 has been well tolerated at the doses administered, and has shown target engagement of TLR7 and TLR9.
The Phase 2 trial is a randomized, double-blind, and placebo-controlled study of IMO-3100 in patients with psoriasis. The trial is designed to evaluate the safety and markers of efficacy of IMO-3100 as a monotherapy. In the study, 45 patients with moderate to severe plaque psoriasis will receive IMO-3100 at 0.16 or 0.32 mg/kg or placebo (saline) by subcutaneous injection once weekly for four weeks. Assessments of safety will be performed throughout the treatment and follow-up periods. Psoriasis intensity will be monitored throughout the study. Skin biopsies of an active psoriasis plaque will be obtained prior to treatment and one week after the last treatment, and will be analyzed by immunohistologic staining for changes in epidermal thickness, immune cell infiltrates and cytokine expression. This trial is being conducted at multiple sites in the United States, and skin biopsies will be analyzed at a central laboratory.