Idera Announces Publication of New Data Demonstrating Impact of Inhibiting
TLRs 7, 8, and 9 in a Preclinical Model of Autoimmune Disease
CAMBRIDGE, Mass. -- January 22, 2014
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), a clinical stage biopharmaceutical
company developing a novel therapeutic approach for the treatment of
autoimmune diseases and genetically defined forms of B-cell lymphoma, today
announced the publication of a study supporting the potential role of the
suppression of Toll-like-receptors (TLRs) 7, 8, and 9 in the treatment of
psoriasis. The data were published in the scientific journal PLOS ONE.
In the publication, entitled Suppression of Molecular Inflammatory Pathways by
Toll-Like Receptor 7, 8, and 9 Antagonists in a Model of IL-23-Induced Skin
Inflammation, data are presented from a study of an antagonist of TLRs 7 and 9
and an antagonist of TLRs 7, 8, and 9. The IL-23-induced mouse model of skin
inflammation was chosen due to its histological and molecular resemblance to
human psoriasis, including the involvement of the IL-17 inflammatory pathway.
Gene expression analyses showed that treatment with either antagonist
normalized expression of IL-17-induced genes. Additionally, both antagonists
normalized aberrant expression of keratin 16, an indicator of epidermal
hyperplasia. More of the IL-23 regulated genes were modulated with the
antagonist of TLRs 7, 8, and 9 (36%) than with the antagonist of TLRs 7, and 9
(26%). In addition to IL-17, other inflammatory pathways, including IL-6 and
interferon-gamma, were strongly suppressed by both antagonists. Further
analysis showed that the antagonist of TLRs 7, 8, and 9 down-regulated the
JAK-STAT, IL-23, IL-12, and IL-17 canonical pathways. The results suggest that
IL-23-driven inflammation in mouse skin may be dependent on signaling mediated
by TLRs 7, 8, and 9.
“These results indicate that TLRs 7, 8 and 9 could serve as novel therapeutic
targets in psoriasis vulgaris and other disease with similar pathophysiology,”
stated James G. Krueger, M.D., Ph.D., Head of the Laboratory for Investigative
Dermatology at The Rockefeller University and senior study author.
“These data provide further insight into the mechanisms underlying the
therapeutic effect which we have reported previously in our TLR antagonist
clinical program in psoriasis. Currently, we are conducting a Phase 2 clinical
trial of IMO-8400, an antagonist of TLRs 7, 8, and 9, for the treatment of
patients with moderate-to-severe plaque psoriasis and plan to initiate
clinical development in selected orphan autoimmune indications,” said Robert
D. Arbeit, M.D., Vice President of Clinical Development at Idera.
Authors of the study were Mayte Suárez-Fariñas, Ph.D, Francesca S. Ortenzio,
and James G. Krueger, M.D., Ph.D., from the Laboratory for Investigative
Dermatology at The Rockefeller University; and Robert Arbeit, M.D., and Tim
Sullivan, Ph.D., from Idera Pharmaceuticals. The publication can be found by
visiting PLOS ONE.
About the IMO-8400 Phase 2 trial in moderate-to-severe plaque psoriasis
In September 2013, Idera completed enrollment of the 32 patients initially
planned in the Company’s ongoing randomized, double-blind, placebo-controlled
Phase 2 trial of IMO-8400 in patients with moderate-to-severe plaque
psoriasis. These 32 patients were randomized for treatment at three dose
levels of IMO-8400, 0.075 mg/kg, 0.15 mg/kg and 0.3 mg/kg, or placebo. The
data remain blinded as the follow-up period of the trial continues. All
treatments were well tolerated in the trial, and based on the observed safety
profile, the Company expanded the trial to evaluate a higher dose cohort of
0.6 mg/kg and placebo in up to 12 patients.. The Company expects to report
top-line data from the trial in the first half of 2014.
About Idera Pharmaceuticals, Inc.
Idera's 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
over-activation 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 for use in B-cell lymphomas
harboring the MYD88 L265P mutation. More information on Idera is available at
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 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 FDA or equivalent foreign
regulatory agencies; whether, if the Company's products receive approval, they
will be successfully distributed and marketed; 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 period ended September 30, 2013, 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
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