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Idera Pharmaceuticals and The Myositis Association Join Forces to Advance the Clinical Development of a Novel TLR Antagonist, IMO-8400, for the Treatment of Myositis

August 7, 2014

CAMBRIDGE, Mass. & ALEXANDRIA, Va.--(BUSINESS WIRE)-- Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing nucleic acid therapeutics for patients with cancer and rare diseases, and The Myositis Association (TMA), the only nonprofit organization dedicated to solely serving all patients with inflammatory myopathies, today announced a collaboration to advance a new potential treatment approach for polymyositis and dermatomyositis known as Toll-like receptor (TLR) antagonism. Under the collaboration, Idera and TMA will develop educational programs and resources for patients and healthcare providers, including interactive online chats, on TLR antagonism and opportunities to participate in upcoming clinical research. Idera plans to initiate a clinical trial of its investigational drug candidate IMO-8400, a first-in-class antagonist of TLRs 7, 8 and 9, in polymyositis and dermatomyositis by the end of 2014.

“We are very excited and pleased to work with TMA, a leading myositis patient advocacy association that shares our commitment to advancing new therapies that may improve outcomes for patients living with this rare and painful inflammatory muscle disease,” said Kate Haviland, Vice President of Rare Diseases at Idera Pharmaceuticals. “As we prepare to move our investigational drug candidate IMO-8400 into clinical development for polymyositis and dermatomyositis, we believe that TMA will be instrumental in increasing patient and physician awareness and excitement for opportunities to participate in clinical research involving TLR antagonism.”

“TMA is very pleased to collaborate with Idera to help advance their novel TLR antagonist therapeutic approach in myositis,” said Bob Goldberg, Executive Director of The Myositis Association. “We believe that the work Idera is doing will further the myositis medical field and our understanding of how to better treat patients suffering from this debilitating rare disease.”

Polymyositis and dermatomyositis are devastating, rare inflammatory myopathies that cause inflammation and progressive weakness in muscles. Polymyositis and dermatomyositis patients can develop serious disabilities, including loss of mobility, difficulty breathing and swallowing, and have an increased risk of certain cancers. Dermatomyositis is also accompanied by a purple or red skin rash. There are an estimated 15,000 polymyositis patients and 25,000 dermatomyositis patients in the U.S. alone. Both polymyositis and dermatomyositis have been designated as rare diseases by the U.S. Food and Drug Administration (FDA).

About The Myositis Association

The Myositis Association (TMA) was founded in 1993 by Betty Curry, a patient who identified the need for information and support for inclusion-body myositis patients; then quickly grew to include the other forms of myositis – dermatomyositis and polymyositis. TMA is the only nonprofit organization dedicated to solely serving patients with the inflammatory myopathies. Besides offering free membership to patients, TMA publishes online and print materials for patients and physicians, offers 45 support groups in the U.S., and conducts an Annual Patient Conference and Myositis Symposium to connect international myositis experts with the myositis medical and patient communities. TMA’s research program has funded 37 grants and fellowships, totaling more than $4.4 million, in the past 11 years.

About IMO-8400

Idera’s Toll-like receptor (TLR) antagonist drug candidates have been created using a proprietary chemistry-based drug discovery platform. IMO-8400 is a first-in-class synthetic oligonucleotide-based antagonist of TLRs 7, 8, and 9. In April 2014, Idera presented preclinical data at the American Association for Cancer Research Annual Meeting from preclinical studies in which IMO-8400 inhibited the survival and proliferation of human B-cell lymphoma cells harboring the oncogenic MYD88 L265P genetic mutation. IMO-8400 also has shown activity in preclinical studies of autoimmune diseases, including psoriasis, lupus, and arthritis. IMO-8400 has been well-tolerated in a Phase 1 trial in 42 healthy subjects at single and multiple escalating doses up to 0.6 mg/kg for four weeks, and has shown inhibition of immune responses mediated by TLRs 7, 8, and 9. In March 2014, Idera announced top-line data from an ongoing Phase 2 trial that showed evidence of clinical activity in patients with psoriasis who were treated with IMO-8400 at doses of up to 0.3 mg/kg/week for 12 weeks. Idera is pursuing clinical development of IMO-8400 in genetically defined forms of B-cell lymphoma, including WaldenstrÖm’s macroglobulinemia and diffuse large B-cell lymphoma harboring the MYD88 L265P mutation, and in rare autoimmune diseases, including polymyositis, dermatomyositis and graft versus host disease.

About Idera Pharmaceuticals, Inc.

Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic approach for the treatment of genetically defined forms of B-cell lymphoma and rare autoimmune diseases. Idera’s proprietary technology involves creating novel nucleic acid therapeutics designed to inhibit over-activation of Toll-like Receptors (TLRs). In addition to its TLR programs, Idera is developing gene silencing oligonucleotides (GSOs) that it has created using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA.

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, cash resources, financial position, future revenues, projected costs, 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 will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera’s technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; whether the Company’s collaborations will be successful; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2014. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.




Idera Pharmaceuticals, Inc.

James Baker, 617-679-5516

jbaker@iderapharma.com

Source: Idera Pharmaceuticals, Inc.


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