Presents IMO-8400 Preclinical Data Supporting Autoimmune Activity at
ACR/AHRP 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 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 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 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.
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com