Idera Pharmaceuticals (Idera) has initiated Phase 1 clinical trial of IMO-3100, an antagonist of Toll-like Receptor (TLR) 7 and TLR9. IMO-3100 is a DNA-based antagonist of Toll-like Receptor (TLR) 7 and TLR9, which has shown to supress immune responses mediated through TLR7 and TLR9, including induction of interferon-alpha, TNF-alpha, IP-10, IL-6, and activation of B cells.
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In the Phase 1 trial, IMO-3100 is being administered by subcutaneous injection to healthy subjects in a rising single-dose design. The primary objective is to evaluate safety and tolerability. Whereas, the secondary objectives are to characterise the pharmacokinetic profile of IMO-3100 and to assess the pharmacodynamic mechanism of action through measurement of the ex vivo response of PBMCs to TLR7 and TLR9 agonists. The trial is being conducted at a single US site.
The company plans to use the results from the rising single-dose trial to select dosages for an anticipated follow-up trial in healthy subjects, the purpose of which would be to characterise safety, pharmacokinetics, and ex vivo pharmacodynamic mechanism of action with weekly subcutaneous administration for four weeks.
The company said that based on the data from these two planned Phase 1 trials, the company intends to identify an autoimmune disease indication for further clinical development of IMO-3100 by the end of 2010.
Sudhir Agrawal, chief scientific officer and CEO of Idera, said: “As an antagonist of TLR7 and TLR9, IMO-3100 has a novel mechanism of action and presents a potentially innovative approach in the treatment of a number of autoimmune diseases. IMO-3100 is our fourth compound to advance into clinical development, each for a different therapeutic application.”
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