Idera Pharmaceuticals Provides Development Update on IMO-9200, an Antagonist of Toll-like Receptors
Company Completed Phase 1 Trial in Healthy Subjects Which Demonstrated IMO-9200 Safe and Well-tolerated Across All Dose Regimens
Pre-Clinical Data Supporting IMO-9200 as an Oral Therapeutic Option to Treat Inflammatory Bowel Disease Presented at 2015
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
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
About Toll-Like Receptors (TLRs) and Idera's Proprietary TLR Antagonist Technology Platform
Toll-like receptors (TLRs) play a central role in the innate immune system and in regulating inflammation, and published data have implicated TLR dysfunction across a broad range of autoimmune diseases and genetically defined forms of B-cell lymphoma.
In autoimmune diseases, endogenous nucleic acids released from damaged or dying cells initiate signaling cascades through TLRs, inducing multiple cytokines. Subsequent inflammation causes further damage to the body's own tissues and organs and the release of more self-nucleic acids. Thus, a pathological amplification cycle is established, promoting disease progression.
In B-cell lymphomas characterized by the MYD88 L265P genetic mutation, an oncoprotein is produced that over activates TLR-initiated signaling, thereby activating transcription factors that promote the survival and proliferation of tumor cells.
Based on the company's proprietary chemistry-based discovery platform, Idera designed and developed two synthetic oligonucleotide-based TLR antagonists, IMO-8400 and IMO-9200. These clinical-stage candidates have demonstrated activity in multiple preclinical models of autoimmune disease and cancer, including psoriasis, lupus, arthritis, and MYD88 L265P-positive B-cell lymphoma.
About Idera Pharmaceuticals
Forward- Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the company's strategy, future operations, collaborations, intellectual property, prospects, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether results obtained in preclinical studies and clinical trials such as the results described in this release with respect to IMO-9200 will be indicative of the results that will be generated in future clinical trials; whether products based on Idera's technology will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the
CONTACT: Investor and Media Contact
Robert Doody
Vice President, Investor Relations and
Corporate Communications
484-639-7235
rdoody@iderapharma.com
