Idera Pharma Offers Development Update Related to IMO-9200: Pre-Clinical Data Shows Support of Candidate for Oral Therapeutic Option to Treat IBD

Idera Pharmaceuticals, Inc.

, a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced the achievement of key development milestones for its product candidate IMO-9200, an antagonist of Toll-like receptors (TLRs) 7, 8 and 9. Specifically, the company today 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 (IBD) at the 2015 Digestive Disease Week Conference (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 (DDW). 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," (Abstract #Sa1757) 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 (IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC). Crohn's disease and UC are severe and debilitating autoimmune disorders characterized by chronic inflammation in the gastrointestinal tract. A copy of the poster can be found on Idera's corporate website: http://www.iderapharma.com/our-science/key-presentations-and-publications. Presented data showed orally-delivered IMO-9200 treatment improved body weight and survival, with corresponding improvements in colon weight, length and histology, in a TNBS-induced Crohn's disease model. In addition, data showed that IMO-9200 treatment improved pro-inflammatory cytokine gene expression and levels in the colon and serum, and restored the TGF-β/SMAD3 signaling pathway. Comparable results for IMO-9200 were observed in a separate DSS-induced UC model, including a reduction on the Colitis Disease Activity Index (CDAI). Collectively, these data demonstrate that TLRs are an important therapeutic target in IBD, and specific blocking of TLRs 7, 8 and 9 with oral IMO-9200 has the potential to disrupt the autoimmune cycle, reduce chronic intestinal inflammation, and improve disease symptoms. Previously conducted preclinical studies have demonstrated the activity of IMO-9200 in mouse models of other autoimmune diseases, including the MRL/lpr model of lupus, the collagen antibody-induced arthritis model of rheumatoid arthritis, and the IL-23-induced dermal inflammation model of psoriasis. "These data demonstrating the potential activity of IMO-9200 delivered either orally or subcutaneously as a novel therapeutic option for patients suffering from autoimmune diseases are encouraging and provide strong support for advancement into further clinical development," stated Vincent Milano, Chief Executive Officer of Idera Pharmaceuticals. "As we noted at the outset of this year, the strategic focus of Idera is directed towards oncology and rare diseases and as such, we are currently reviewing our various strategic options for the future of the IMO-9200 development program."