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news.Idera Pharmaceuticals has initiated Phase II trial of IMO-3100, the Toll-like receptor (TLR) inhibitor for the treatment of autoimmune diseases, in patients with moderate to severe plaque psoriasis.
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IMO-3100 is an immunomodulator that inhibits the activity of TLR7 and TLR9 and modulates the production of multiple pro-inflammatory mediators.
The randomized, double-blind, and placebo-controlled study 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 0.32mg/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.
Idera chairman and chief executive officer Sudhir Agrawal said the company expects expansion of its pipeline in autoimmune diseases with the advancement of IMO-8400 for the treatment of lupus following the anticipated submission of an investigational new drug application with the FDA 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," Agrawal added.