“We are very pleased to initiate this clinical trial for patients living with dermatomyositis,” stated Kate Haviland, Idera’s Vice President of Rare Diseases. “Based on preclinical and clinical studies demonstrating the role of Toll-like receptors in dermatomyositis and other immune-mediated inflammatory diseases, we believe IMO-8400 has the potential to play an important role in the treatment of this serious disease. In partnership with leading global myositis experts, we carefully designed this new Phase 2 trial in dermatomyositis to define the safety and efficacy profile of IMO-8400, as well as contribute data that will advance the myositis community’s understanding of the disease.”
“The myositis community is excited by the start of this important clinical trial,” said Bob Goldberg, Executive Director of The Myositis Association. “Dermatomyositis is a severe and disabling disease that can limit the ability of patients to perform activities of daily living, maintain employment and lead full independent lives. For many patients, currently available treatments do not effectively control their disease and/or are not well tolerated. New targeted therapies such as IMO-8400 will hopefully improve patient outcomes.”
The Phase 2, randomized, double-blind, placebo-controlled clinical trial is designed to assess the safety, tolerability and treatment effect of IMO-8400 in adult patients with dermatomyositis. Eligibility criteria include evidence of active skin and muscle involvement. Once enrolled, patients will be randomized to 1 of 4 groups to receive once weekly subcutaneous injections of: placebo, or 0.06 mg/kg, 0.2 mg/kg, or 0.6 mg/kg of IMO-8400 for a period of 24 weeks. The study is expected to enroll approximately 48 patients and is being conducted at approximately 20 centers in the United States and United Kingdom. The primary efficacy endpoint is the change from baseline in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), a validated outcome measure of skin disease. Additional exploratory endpoints include muscle strength and function, the International Myositis Assessment & Clinical Studies Group (IMACS) core set measures, patient-reported quality of life and biochemical markers of disease activity.
About Dermatomyositis
Dermatomyositis is a rare, debilitating, inflammatory muscle and skin disease associated with significant morbidity, decreased quality of life and an increased risk of premature death. While the cause of dermatomyositis is not well understood, the disease process involves immune system attacks against muscle and skin that lead to inflammation and tissue damage. Major symptoms can include progressive muscle weakness, severe skin rash, calcium deposits under the skin (calcinosis), difficulty swallowing (dysphagia) and interstitial lung disease. Dermatomyositis affects approximately 25,000 people in the United States, and is about twice as common in women as men, with a typical age of onset between 45 and 65 years in adults. Dermatomyositis represents one form of myositis, a spectrum of inflammatory muscle diseases that also includes juvenile dermatomyositis, polymyositis and inclusion body myositis.
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 several autoimmune diseases. 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 2015, Idera announced data from a Phase 2 trial that showed evidence of clinical activity in patients with psoriasis who were treated with IMO-8400 at doses of up to 0.6 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 immune-mediated inflammatory diseases.
About Idera Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage patient focused biopharmaceutical company developing novel therapeutic approaches for the treatment of cancer and rare diseases. Idera’s proprietary technology involves creating novel nucleic acid therapeutics. Idera’s immunotherapy approach is based on the modulation of Toll-like receptors (TLRs). In addition to its TLR modulation programs, Idera is developing third generation antisense technology that it has created to inhibit the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.
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, including statements about potential treatments for dermatomyositis. Such statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on the company’s current beliefs and expectations. Development of drug therapies involves a high degree of risk, and only a small percentage of research and development programs undertaken may result in the commercialization of a product. Positive preclinical data does not ensure that later stage clinical trials will be successful. There can be no assurance that the clinical trial referred to herein will achieve the stated objectives or that administration of IMO-8400 will prove to have any clinical benefit whatsoever. For more detailed information on the risks and uncertainties associated with Idera’s development activities, please review the Risk Factors section of Idera's most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the company assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor and Media ContactRobert DoodyVice President, Investor Relations and Corporate Communications484‐639‐7235[email protected]
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