Idera Announces Clinical Development Progress in Its Autoimmune Diseases Program
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Idera Pharmaceuticals, Inc. (NAS: IDRA) today announced that it has completed dosing in its Phase 1 trial of IMO-8400 in healthy subjects. In addition, the Company announced that its protocol for a Phase 2 study of IMO-8400 in patients with psoriasis has received "no objection" clearance from the Competent Authority of the Netherlands. IMO-8400 is an antagonist of Toll-like receptors (TLRs) 7, 8 and 9, and is in clinical development for the treatment of autoimmune diseases.
During the first quarter of 2013, the Company completed the escalating single-dose portion of the Phase 1 trial of IMO-8400 and has now completed patient dosing in the multiple-dose portion of the trial. The multiple-dose portion of the trial involved two dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects receiving each treatment of four weekly doses. The Company expects to report top-line data from the multiple-dose portion of the trial later in the second quarter of 2013.
The Company also announced that the protocol that it has submitted for a Phase 2 trial of IMO-8400 in patients with psoriasis has received "no objection" clearance from the Competent Authority of the Netherlands. Under the protocol for this trial, 32 patients would be randomized to receive weekly doses for up to 12 weeks at one of three dose levels or placebo. The Company does not plan to commence this trial until it has reviewed the results from the Phase 1 trial of IMO-8400 and obtained the resources to fund the Phase 2 trial.
"We have made steady progress in advancing IMO-8400 in our autoimmune disease program," said Robert Arbeit, M.D., VP of Clinical Development at Idera. "We have completed four-week dosing of IMO-8400 at two dose levels in healthy subjects, and are now in position to progress to a Phase 2 trial. We are pleased to have regulatory clearance of our Phase 2 protocol in patients with moderate-to-severe plaque psoriasis."
The Company further announced that an analysis of biopsy samples from its previous Phase 2 trial of IMO-3100 in patients with psoriasis has been conducted by James G. Krueger, M.D., Ph.D, of The Rockefeller University. In these samples, the Company observed a gene expression profile that is consistent with treatment-related improvement in psoriasis disease-associated genes, including the IL-17 pathway.
"Top-line microarray results of the clinical samples show significant improvement of psoriasis disease-associated gene profile in patients treated with IMO-3100 compared to placebo," said Dr. Krueger. "Importantly, the IL-17 pathway, which is central to the pathogenesis of psoriasis, was down-regulated in samples from treated patients."
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of autoimmune and inflammatory diseases by targeting specific Toll-like Receptors (TLRs) to inhibit the induction of immune responses. The Company has two drug candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and 9, and IMO-3100, an antagonist of TLR7 and 9. Additionally, Idera has a collaboration with Merck & Co. for the use of TLR agonists as vaccine adjuvants for cancer, infectious diseases and Alzheimer's disease. For more information, visit http://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, including whether Idera's cash resources will be sufficient to fund the Company's continuing operations and the development of the Company's autoimmune disease program; whether results obtained in preclinical studies and early clinical trials will be indicative of results obtained in future 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 will be able to license any of its TLR target candidates on a timely basis or at all; whether the Company's collaboration with Merck & Co, Inc., 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; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Annual Report on Form 10-K for the year ended December 31, 2012 which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
KEYWORDS: United States North America Massachusetts
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