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March 13, 2014
07:36 EDTIDRAIdera announces expansion of pipeline into two orphan autoimmune diseases
Idera Pharmaceuticals announced that it plans to initiate clinical development of its lead compound, IMO-8400, for the treatment of patients with polymyositis and patients with dermatomyositis, two orphan autoimmune diseases with high unmet clinical needs. The company plans to submit a protocol to the U.S. Food and Drug Administration in the first half of 2014 for a Phase 1/2 clinical trial to investigate the safety and potential utility of IMO-8400 in these two indications. This represents the execution of a previously announced strategy to expand the clinical development of IMO-8400 in orphan autoimmune disease indications. Based on the results from this study, Idera anticipates that it will pursue separate later-stage clinical trials for each indication.
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May 18, 2015
08:52 EDTIDRAIdera Pharmaceuticals provides development update on IMO-9200
Idera Pharmaceuticals announced the achievement of key development milestones for its product candidate IMO-9200, an antagonist of Toll-like receptors, or TLRs, 7, 8 and 9. Specifically, the company reported top-line data from a Phase 1 clinical trial of IMO-9200 in healthy subjects and announced the presentation of new preclinical data for IMO-9200 in models of inflammatory bowel disease, or IBD, at the 2015 Digestive Disease Week Conference, or DDW, in Washington, DC. In the placebo-controlled Phase 1 clinical trial in 30 healthy subjects, IMO-9200 was administered by subcutaneous injection at escalating single-dose levels of 0.1, 0.3, and 0.5 mg/kg. In the multiple dose cohort, a dose of 0.5 mg/kg/week for four weeks was also evaluated. All dose regimens were well tolerated, with no serious adverse events related to IMO-9200 treatment reported. There were no patterns of laboratory or other safety parameters suggestive of any related adverse treatment effect. Additionally, new preclinical data for IMO-9200 were presented on Saturday, May 16 at the 2015 Digestive Disease Week Conference. The poster presentation, entitled "Targeting Innate Immune Receptors to Treat Inflammatory Bowel Disease: Activity of Oral IMO-9200, an Antagonist of TLRs 7, 8, and 9 in Mouse Models of Colitis," provided results from two mouse models of colitis. These results demonstrated the potential of orally dosed IMO-9200 as a treatment for inflammatory bowel disease, which includes Crohn's disease, or CD, and ulcerative colitis.

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