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May 13, 2014
07:03 EDTIDRAIdera Pharmaceuticals reports Q1 EPS (12c), two estimates (8c)
Reports Q1 revenue $3,000, two estimates $3,000. The company anticipates enrolling up to approximately 30 patients in a Phase 1/2 trial of IMO-8400 in patients with trial DLBCL who harbor the MYD88 L265P mutation and have relapsed or were refractory to prior therapy. The company expects to initiate patient treatment in the second half of 2014. A Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström’s macroglobulinemia, who have relapsed or were refractory to prior therapy, is ongoing. This trial is designed to evaluate safety, tolerability and clinical activity of escalating IMO-8400 dose levels. The Company anticipates enrolling up to approximately 30 patients in this trial. In March, the company announced positive top-line data from a randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. The trial met the primary objective of demonstrating safety and tolerability, as well as a secondary objective of clinical activity of IMO-8400. The company intends to submit the full data set, including data from an additional higher dose cohort, for presentation at a medical meeting in 2014.
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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.
May 11, 2015
07:38 EDTIDRAIdera Pharmaceuticals reports Q1 EPS (12c), consensus (11c)
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