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Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the receipt of verbal notification from the Food and Drug Administration (FDA) that the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis based on a trial protocol submitted by the company in October 2011. IMO-3100 is a dual antagonist of Toll-like receptor (TLR) 7 and TLR9 and is in clinical development as a potential therapy for autoimmune and inflammatory diseases.
“We are pleased to have the FDA’s notification that we can proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer of Idera. “We are now preparing for this Phase 2 trial of our novel dual-TLR antagonist for the treatment of autoimmune diseases and expect to initiate the study in the first half of 2012.”
Idera has selected psoriasis as the initial indication for the first clinical evaluation of IMO-3100 in patients with autoimmune disease. In July 2011, the company submitted a Phase 2 protocol to evaluate IMO-3100 in patients with psoriasis over a 12-week treatment period. As previously announced, this protocol was put on clinical hold by the FDA. In October 2011, the company submitted a new Phase 2 protocol to evaluate IMO-3100 in patients with psoriasis over a 4-week treatment period, for which the company has received notification of FDA authorization to proceed.
IMO-3100, an antagonist of TLR7 and TLR9, is a lead clinical candidate in development to treat autoimmune and inflammatory diseases. IMO-3100 is designed to block production of multiple cytokines induced through TLR7 and TLR9. In contrast, many current autoimmune disease treatments aim to block the activity of individual cytokines. IMO-3100 has demonstrated potent activity in reducing pathologic and immunologic manifestations in preclinical mouse models of diseases such as lupus, arthritis, psoriasis and hyperlipidemia. Phase 1 clinical trials of IMO-3100, including an escalating single-dose study and a multiple-dose study, have been completed in healthy subjects.