CAMBRIDGE, Mass.--(EON: Enhanced Online News)--Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today will provide a further update on its autoimmune program, and its plans for initiating clinical development in genetically defined forms of B-cell lymphoma, in a presentation at the Stifel Nicolaus 2013 Healthcare Conference in Boston.
“The Idera team has significantly strengthened the company by advancing our lead clinical program, moving quickly to develop a tightly focused program in lymphoma, and accelerating its efforts to expand our pipeline”
Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals, and Jim Geraghty, Chairman of Idera’s Board of Directors, will highlight several ways in which the company has recently strengthened its business. They will provide an update on progress in the company's ongoing Phase 2 trial of its lead candidate, IMO-8400, a TLR 7, 8 and 9 antagonist, present the path forward for the company’s recently announced B-cell lymphoma program, and describe the company’s plans to expand its pipeline with the development of additional preclinical compounds.
Idera’s B-cell lymphoma program leverages an emerging scientific understanding of the central role that Toll-like Receptors (TLRs) 7 and 9 play in several forms of B-cell lymphoma with specific mutations, including activated B-cell-like diffuse large B-cell lymphoma (ABC-DLBCL), Waldenström’s macroglobulinemia, and others. The company’s proprietary TLR antagonists have been shown to effectively inhibit TLR 7 and 9 in preclinical studies and in a completed Phase 2 clinical proof-of-concept study in psoriasis.
Existing safety data on IMO-8400 would enable Idera to submit an IND for IMO-8400 in Q4 2013, and initiate a Phase 1/2 clinical trial of IMO-8400 in lymphoma patients with these specific mutations in Q1 2014. The company is currently considering its options for financing this program, and would begin clinical development following the successful completion of these plans.
“We are making rapid progress in turning emerging findings in certain forms of B-cell lymphoma into a clinical development program, and hope to begin dosing the first patients early next year,” Dr. Agrawal said. “Despite notable advances, success in treating B-cell lymphoma has been limited, and patients with certain genetically defined mutations remain in desperate need of new treatments. We believe the limited number and severe condition of these patients may support regulatory designations that would allow us to advance these programs rapidly.”
Idera also will provide an update on its strategy for its autoimmune program at the conference. Idera plans to prioritize orphan indications it could develop itself while developing programs in psoriasis and other large indications through collaborations with larger companies. Idera is developing additional TLR antagonist compounds for use in psoriasis and other autoimmune diseases, with the goal of offering patients a new therapeutic option that could address the shortcomings of currently available biologics by providing improved safety, tolerability and disease remission.
The company expects to complete enrollment in its ongoing Phase 2 trial of IMO-8400 for moderate-to-severe psoriasis this month, and to have top-line data available in the first quarter of 2014. To date, IMO-8400 has been well tolerated in the trial, with no treatment-related discontinuations. Idera believes that TLR antagonists can address an important need in the psoriasis treatment continuum by offering an additional option to be used before progression to biologics.
“The Idera team has significantly strengthened the company by advancing our lead clinical program, moving quickly to develop a tightly focused program in lymphoma, and accelerating its efforts to expand our pipeline,” said Jim Geraghty. “As we build on new findings showing the potential of TLR antagonists in genetically defined forms of B-cell lymphoma, we're committed to bringing effective therapies to patients and value to our shareholders."
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals' technology platform involves creating novel synthetic RNA- and DNA-based compounds to modulate immune responses. Idera has applied this platform to develop proprietary Toll-like receptor (TLR) antagonists as immunomodulatory drug candidates. Toll-like receptor antagonists block the overactivation of immune factors which can cause a range of pathological effects. Idera is conducting clinical development of TLR antagonists in autoimmune and inflammatory diseases, and preclinical development of their use in certain genetically defined forms of B-cell lymphoma. More information on Idera is available at iderapharma.com.
Forward Looking Statements
This press release includes statements concerning Idera Pharmaceuticals, Inc. and its future expectations, plans and prospects that constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements, including whether Idera’s cash resources will be sufficient to fund the Company’s continuing operations and the further development of the Company’s programs, including the planned Phase 1/2 trial, and whether Idera can obtain needed resources on a timely basis or at all; whether results obtained in early research, preclinical studies and clinical trials will be indicative of the results that will be generated in future preclinical and clinical studies; 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 will be able to enter into collaborations that will advance the development of its compounds for autoimmune disease indications; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Quarterly Report on Form 10-Q for the quarter ended June 30, 2013. Idera disclaims any intention or obligation to update any forward-looking statements.