CAMBRIDGE, Mass., Jan 28, 2010 (BUSINESS WIRE) -- Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced initiation of
a Phase 1 clinical trial of IMO-3100, an antagonist of Toll-like
Receptor (TLR) 7 and TLR9.
"As an antagonist of TLR7 and TLR9, IMO-3100 has a novel mechanism of
action and presents a potentially innovative approach in the treatment
of a number of autoimmune diseases," said Sudhir Agrawal, D.Phil., Chief
Executive Officer and Chief Scientific Officer. "IMO-3100 is our fourth
compound to advance into clinical development, each for a different
therapeutic application."
"Our first step in the clinical evaluation of IMO-3100 is to assess the
safety and mechanism of action in healthy subjects," said Tim Sullivan,
Ph.D., Vice President of Development Programs. "We have observed
exciting results that show IMO-3100 ameliorates the pathologic findings
observed in preclinical models of various autoimmune diseases, including
lupus, rheumatoid arthritis, and psoriasis. Data from this Phase 1
clinical trial will support our decisions regarding subsequent clinical
development of IMO-3100."
About IMO-3100
IMO-3100 is a DNA-based antagonist of Toll-like Receptor (TLR) 7 and
TLR9, which has been shown in preclinical assays to suppress immune
responses mediated through TLR7 and TLR9, including induction of
interferon-alpha, TNF-alpha, IP-10, IL-6, and activation of B cells.
Studies from independent researchers have suggested that immune
complexes involved in certain autoimmune diseases induce inflammatory
responses mediated through TLR7 and TLR9. Use of a TLR antagonist to
block responses to such immune complexes may provide a potentially
innovative approach for the treatment of autoimmune diseases. In
preclinical mouse models of autoimmune diseases including lupus,
rheumatoid arthritis, and psoriasis, IMO-3100 has shown potent activity
in reducing pathologic and immunologic manifestations of disease. Idera
continues to evaluate IMO-3100 and other TLR antagonist drug candidates
in additional preclinical models of autoimmune, inflammatory, and
hyperlipidemia diseases.
Idera has evaluated IMO-3100 for its pharmacodynamic mechanism of action
in non-human primates. In this study, the ex vivo response of
peripheral blood mononuclear cells (PBMCs) to TLR7 and TLR9 agonists was
assessed at various times after subcutaneous administration of IMO-3100
to non-human primates. The Company plans to present data from this
preclinical study at a scientific meeting in the first quarter of 2010.
About the Trial (Study 3100-001)
In this Phase 1 trial, IMO-3100 is being administered by subcutaneous
injection to healthy subjects in a rising single-dose design. The
primary objective is to evaluate safety and tolerability. Secondary
objectives are to characterize the pharmacokinetic profile of IMO-3100
and to assess the pharmacodynamic mechanism of action through
measurement of the ex vivo response of PBMCs to TLR7 and TLR9
agonists. The trial is being conducted at a single U.S. site.
The Company plans to use the results from this rising single-dose trial
to select dosages for an anticipated follow-up trial in healthy
subjects, the purpose of which would be to characterize safety,
pharmacokinetics, and ex vivo pharmacodynamic mechanism of action
with weekly subcutaneous administration for four weeks. Based on the
data from these two planned Phase 1 trials, the Company intends to
identify an autoimmune disease indication for further clinical
development of IMO-3100 by the end of 2010.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals develops drug candidates to treat infectious
diseases, autoimmune and inflammatory diseases, cancer, and respiratory
diseases, and for use as vaccine adjuvants. Our proprietary drug
candidates are designed to modulate specific Toll-like Receptors, which
are a family of immune system receptors that direct immune system
responses. Our 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, including whether results
obtained in preclinical studies such as the preclinical studies referred
to in this release 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 with Merck KGaA and an
affiliate of 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; 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 September 30, 2009, which important factors are
incorporated herein by reference. Idera disclaims any intention or
obligation to update any forward-looking statements.

SOURCE: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com