Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced preliminary results from a Phase 1 clinical trial of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for potential applications in autoimmune and inflammatory diseases. In this trial, healthy subjects in five dosage cohorts received single doses of IMO-3100 from 0.04 to 0.64 mg/kg. IMO-3100 was well tolerated at all dose levels. Subjects who received IMO-3100 showed suppression of tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interferon-alpha (IFN-α), and other pro-inflammatory cytokines mediated through TLR7 and TLR9 activation. The Company is planning to present detailed results of the trial at a scientific meeting in the fourth quarter of 2010.
“IMO-3100 is a first-in-class antagonist of TLR7 and TLR9 and provides an innovative approach for the potential treatment of autoimmune and inflammatory diseases. IMO-3100 has shown activity in preclinical models of diseases including lupus, rheumatoid arthritis, psoriasis, and hyperlipidemia”
"We are pleased with the safety of IMO-3100 in this trial at dosages up to 0.64 mg/kg. In addition, the observation that IMO-3100 treatment led to suppression of TLR7- and TLR9-mediated immune responses is consistent with the intended pharmacodynamic mechanism of action," said Robert D. Arbeit, M.D., Vice President of Clinical Development. "Our next step in the clinical development of IMO-3100 is to initiate a four-week repeat-dose trial in healthy subjects in the third quarter of 2010. We plan to design the trial to evaluate multiple-dose safety and the duration of the pharmacodynamic effect."
"IMO-3100 is a first-in-class antagonist of TLR7 and TLR9 and provides an innovative approach for the potential treatment of autoimmune and inflammatory diseases. IMO-3100 has shown activity in preclinical models of diseases including lupus, rheumatoid arthritis, psoriasis, and hyperlipidemia," said Sudhir Agrawal, D.Phil., Chief Executive Officer and Chief Scientific Officer. "We expect that safety and pharmacodynamic mechanism of action data from our IMO-3100 clinical trials in healthy subjects will help us move rapidly into clinical evaluation of IMO-3100 in selected autoimmune disease indications."
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