Idera Pharmaceuticals, Inc. (IDRA) said it has completed dosing in its Phase 1 trial of IMO-8400 in healthy subjects. Further, the company reported that its protocol for a Phase 2 study of IMO-8400 in patients with psoriasis has received "no objection" clearance from the Competent Authority of the Netherlands. IMO-8400 is an antagonist of Toll-like receptors or TLRs 7, 8 and 9, and is in clinical development for autoimmune diseases treatment.
During the first quarter of 2013, the Company completed the escalating single-dose portion of the Phase 1 trial of IMO-8400 and has now completed patient dosing in the multiple-dose portion of the trial. The multiple-dose portion of the trial involved two dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects receiving each treatment of four weekly doses. The Company expects to report top-line data from the multiple-dose portion of the trial later in the second quarter of 2013.
Additionally, the company announced that the protocol that it has submitted for a Phase 2 study of IMO-8400 in patients with psoriasis has received "no objection" clearance from the Competent Authority of the Netherlands. As per the protocol, 32 patients would be randomized to receive weekly doses for up to 12 weeks at one of three dose levels or placebo. The company does not plan to begin this trial until it has reviewed the results from the Phase 1 trial of IMO-8400 and obtained the resources to fund the Phase 2 study.
Further, the company added that an analysis of biopsy samples from its prior Phase 2 study of IMO-3100 in patients with psoriasis has been conducted by James G. Krueger, M.D., Ph.D, of The Rockefeller University. In these samples, the company observed a gene expression profile that is consistent with treatment-related improvement in psoriasis disease-associated genes, including the IL-17 pathway.
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