Idera Reports Clinical Hold on Proposed Phase 2 Clinical Trial of IMO-3100
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 20, 2011 - Idera Pharmaceuticals (Nasdaq: IDRA) today announced the receipt of a verbal communication from the U.S. Food and Drug Administration (FDA) that a proposed Phase 2 protocol that the Company had recently submitted under an Investigational New Drug Application for IMO-3100 will be placed on a clinical hold. The proposed Phase 2 trial of IMO-3100 is for the treatment of psoriasis. A clinical hold is an order issued by the FDA to the sponsor of a clinical trial to delay a proposed clinical trial or suspend an ongoing clinical trial. IMO-3100 is a TLR7 and TLR9 antagonist being developed for the treatment of autoimmune diseases.
The Company has not yet received a written communication from the FDA regarding the clinical hold. Once the Company has received the FDA's official communication, it will review the content and determine its next steps.
The Company has completed two Phase 1 clinical trials of IMO-3100 in healthy subjects, including an escalating single-dose study and a multiple-dose study. In these studies IMO-3100 was well tolerated and target engagement of TLR7 and TLR9 was observed.
IMO-3100, an antagonist of TLR7 and TLR9, is a lead clinical candidate in development to treat autoimmune and inflammatory diseases. IMO-3100 is designed to block production of multiple cytokines induced through TLR7 and TLR9. In contrast, many current autoimmune disease treatments aim to block the activity of individual cytokines. IMO-3100 has demonstrated potent activity in reducing pathologic and immunologic manifestations in preclinical mouse models of diseases such as lupus, arthritis, psoriasis and hyperlipidemia. Phase 1 clinical trials of IMO-3100, including an escalating single-dose study and a multiple-dose study, have been completed in healthy subjects.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat chronic hepatitis C virus infection, autoimmune and inflammatory diseases, cancer, and respiratory diseases, and for use as vaccine adjuvants. The company's proprietary drug candidates are designed to modulate specific Toll-like Receptors, which are a family of immune system receptors. Idera's pioneering DNA and RNA chemistry expertise enables us to create drug candidates for internal development and generates opportunities for multiple collaborative alliances. For more information, visit www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. 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; whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in clinical trials; 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; whether the patents and patent applications owned or licensed by the Company will protect the Company's technology and prevent others from infringing it; whether Idera's cash resources will be sufficient to fund the Company's operations; 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 three months ended March 31, 2011, which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
Posted: July 2011