Submission of an Investigational New Drug Application Expected During
the Fourth Quarter of 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 21, 2012--
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced results from
preclinical studies evaluating the mechanism of action of IMO-8400, a
selective inhibitor of Toll-like Receptors (TLRs) 7, 8, and 9. The data
were presented on Wednesday, June 20, during the Federation of Clinical
Immunology Societies (FoCIS) meeting being held June 20-23, 2012, in
Vancouver, BC, Canada.
In this study, the mechanism of action of IMO-8400 has been studied in
non-human primates. The administration of IMO-8400 led to inhibition of
immune responses mediated through targeted Toll-like receptors. Multiple
cytokines were suppressed, including TNF-α, IL-12, IL-6, IFN-α, IL-1β.
Similar results of IMO-8400 suppression of TLR7, 8 and 9-mediated immune
responses were observed in human blood cells. IMO-8400 is a lead
candidate in development for the treatment of lupus.
"These studies confirm that in a preclinical primate model and in human
blood cells treatment with IMO-8400 specifically blocked cytokine
induction mediated through targeted TLRs," said Tim Sullivan, VP of
Development Programs and Alliance Management. "The selective inhibition
of these TLRs is consistent with the preclinical efficacy we have seen
in commonly used mouse models of lupus and holds promise for potential
use of IMO-8400 in humans with lupus and other autoimmune diseases. The
activity demonstrated with IMO-8400 in various models forms the basis
for the Investigational New Drug Application we anticipate submitting to
the FDA in the fourth quarter of this year."
About TLRs and Idera's Pipeline
Toll-like Receptors (TLRs) represent a class of proteins that play a key
role in both inflammation and immunity. Of the 10 human TLRs identified
to date, Idera is focusing on compounds targeted to TLRs 3, 7, 8, and 9,
which are expressed in different cells and serve unique functions. For
example, activation of TLR7 and TLR9 present in certain dendritic cells
and lymphocytes may be useful for the treatment of various types of
cancer by stimulating immunity. In contrast, inhibition of specific TLRs
may be useful in treating autoimmune disorders, such as psoriasis and
lupus, by blocking the production of multiple pro-inflammatory
mediators. Using its chemistry-based approach, Idera has developed novel
drug candidates which modulate immune response through activation or
inhibition of specific TLRs to treat a broad range of diseases,
including autoimmune diseases and cancer, and to enhance the
effectiveness of vaccines.
In autoimmune diseases, Idera is developing inhibitors of TLRs 7, 8, and
9 for the potential treatment of psoriasis, lupus, and other diseases.
Idera's lead clinical candidate is IMO-3100, an antagonist of TLR7 and
TLR9, which is in Phase 2 development for psoriasis. IMO-8400 is an
antagonist of TLRs 7, 8, and 9. Idera expects to submit an IND
application for IMO-8400 during the fourth quarter of 2012. Idera has
selected lupus as the initial disease indication for clinical
development of IMO-8400.
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 clinical development programs in autoimmune diseases and cancer.
Additionally, Idera has a collaboration with Merck & Co. for the use of
TLR-targeted candidates as vaccine adjuvants. 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 results
obtained in preclinical studies such as the studies referred to in this
release will be indicative of results obtained in clinical trials;
whether Idera will submit its anticipated IND for IMO-8400 on a timely
basis or at all; 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 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; 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 March 31, 2012 which important factors are incorporated herein by
reference. Idera disclaims any intention or obligation to update any
forward-looking statements.
Erbitux(R) is a registered trademark of ImClone LLC, a wholly-owned
subsidiary of Eli Lilly and Company. Tarceva(R) is a registered
trademark of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma
US, Inc. Avastin(R) is a registered trademark of Genentech, Inc.
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com
