Idera Announces Initiation of Lupus Clinical Development Program with Phase 1 Trial of IMO-8400

  Idera Announces Initiation of Lupus Clinical Development Program with Phase
  1 Trial of IMO-8400

Presents IMO-8400 Preclinical Data Supporting Autoimmune Activity at ACR/AHRP

Business Wire

CAMBRIDGE, Mass. -- November 13, 2012

Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the initiation of
dosing in a Phase 1 trial of IMO-8400. IMO-8400 is an antagonist of Toll-like
receptors (TLRs) 7, 8 and 9, and is the second clinical candidate in Idera’s
autoimmune disease program. Idera expects to develop IMO-8400 for the
treatment of lupus as an initial indication. Idera also announced the
presentation of preclinical data on IMO-8400 at the American College of
Rheumatology that support its potential to treat autoimmune diseases through
inhibition of Th1, Th17, and inflammasome activation.

“We are pleased to have initiated the clinical development of IMO-8400 in our
lupus program,” said Robert Arbeit, MD, Vice President of Clinical Development
at Idera. “IMO-8400 provides a novel approach to the treatment of lupus, by
blocking signaling through Toll-like receptors. In preclinical studies,
lupus-prone mice treated with IMO-8400 demonstrated suppression of multiple
pro-inflammatory cytokines, inhibition of auto-antibody production, and
improvement in renal function, all of which are components of SLE
pathophysiology. These changes are consistent with the intended mechanism of
action of this candidate.”

“The next objectives in our autoimmune disease programs are to have top-line
data for some of the endpoints from our Phase 2 trial of IMO-3100 in patients
with psoriasis by year end 2012 and to complete our Phase 1 trial of
IMO-8400,” said Dr. Sudhir Agrawal, Chief Executive Officer of Idera. “Our
recent raise of $7 million, in addition to the $8.5 million that we had on
hand at the end of the third quarter, we expect will allow us to meet these
near-term objectives.”

The goals of the Phase 1 trial in the clinical development of IMO-8400 are to
assess the safety and pharmacodynamic activity of IMO-8400 in healthy
subjects. A total of 30 healthy subjects are scheduled to receive single or
multiple ascending doses of IMO-8400. Data from this study are expected to be
available during Q2 2013. Following successful completion of the Phase 1 study
and additional funding, the Company expects to initiate a Phase 2 clinical
trial of IMO-8400 in lupus patients.

The company also announced the presentation of preclinical data at the
American College of Rheumatology/Association of Rheumatology Health
Professionals (ACR/ARHP) Annual Meeting being held November 9-14, 2012, in
Washington, D.C The presentation (#1068) is entitled “A selective inhibitor of
endosomal Toll-like Receptors, IMO-8400, suppresses activation of multiple
Th1-type cytokines, Th17 response, and inflammasome activation”. In this
presentation, data showed that in a mouse model of psoriasis, the expression
of multiple cytokines, including Th1-type IL-12 and IL-6; Th17-type IL-17 and
IL-22; and IL-1β, which is associated with inflammasome activation, was
upregulated. In this study, mice treated with IMO-8400 or IMO-3100 showed
suppression of Th1, Th17 and inflammasome activation-related cytokines. In
addition, treatment led to a decrease in dermal thickness and suppression of
keratinocyte peptides, including S100A4, S100A7a, and Defensin β4, compared to
untreated mice.

About IMO-8400

IMO-8400, an antagonist of TLRs 7, 8, and 9, is a lead drug candidate in
development to treat autoimmune diseases, with systemic lupus erythematosus
(lupus) as the first indication for development. In preclinical mouse models
of lupus, treatment with IMO-8400 has led to a reduction in levels of
autoimmune antibodies, including anti-DNA, anti-RNA, and anti-SM, compared to
untreated mice. In addition, improvements in renal function, such as
reductions in blood urea nitrogen, proteinuria, and histopathology changes in
the kidney, were observed in IMO-8400 treated mice. Treatment of mice with
IMO-8400 inhibited multiple disease-associated cytokines and decreased
abnormal gene expression patterns compared to untreated mice.

About Systemic Lupus Erythematosus

Lupus is a chronic autoimmune disease where the body's immune system becomes
hyperactive and attacks normal healthy tissue. This results in symptoms such
as inflammation, swelling, and damage to joints and almost every major organ
in the body, including the heart, kidneys, skin, lungs, and brain. According
to The Lupus Foundation of America, an estimated 1.5 million Americans and at
least five million people worldwide have a form of lupus.

About Idera Pharmaceuticals, Inc.

Idera Pharmaceuticals applies its proprietary Toll-like receptor (TLR) drug
discovery platform to create immunomodulatory drug candidates and has a
clinical development program in autoimmune diseases. Additionally, Idera has a
collaboration with Merck & Co. for the use of TLR-targeted candidates as
vaccine adjuvants for cancer, infectious diseases and Alzheimer’s disease. The
Company is also advancing its gene-silencing oligonucleotide (GSO) technology
for the purpose of inhibiting the expression of disease-promoting genes. For
more information, visit

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 further development of the Company’s
autoimmune disease program; whether results obtained in preclinical studies
and early clinical trials, such as the results from the preclinical studies
referred to in this release, 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 Quarterly Report on Form 10-Q for
the quarter ended September 30, 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
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