- Company to initiate clinical development of IMO-8400 in
polymyositis and dermatomyositis in first half of 2014 -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 13, 2014--
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage
biopharmaceutical company developing a novel therapeutic approach for
the treatment of autoimmune disorders and genetically defined forms of
B-cell lymphoma, today announced that it plans to initiate clinical
development of its lead compound, IMO-8400, for the treatment of
patients with polymyositis and patients with dermatomyositis, two orphan
autoimmune diseases with high unmet clinical needs. The Company plans to
submit a protocol to the U.S. Food and Drug Administration (FDA) in the
first half of 2014 for a Phase 1/2 clinical trial to investigate the
safety and potential utility of IMO-8400 in these two indications. This
represents the execution of a previously announced strategy to expand
the clinical development of IMO-8400 in orphan autoimmune disease
indications. Based on the results from this study, Idera anticipates
that it will pursue separate later-stage clinical trials for each
indication.
“Polymyositis and dermatomyositis are very challenging autoimmune
diseases to manage, and currently there is a need for physicians to
offer new treatments to patients suffering from these conditions,” said
Dr. Chester Oddis, Professor of Medicine, Division of Rheumatology and
Clinical Immunology, University of Pittsburgh. “I am encouraged by the
potential of this novel approach, which is targeted to a key disease
driver and could represent a promising area of investigation for these
life-impacting conditions.”
"Our team of scientists, clinicians, and advisors has prioritized
polymyositis and dermatomyositis among a wide range of orphan autoimmune
diseases that may potentially benefit from our TLR antagonist program.
We are excited to explore the potential of IMO-8400 for the treatment of
patients with these challenging conditions,” remarked Dr. Lou Brenner,
Senior Vice President and Chief Medical Officer of Idera Pharmaceuticals.
Idera’s Toll-like receptor (TLR) antagonist platform is designed to
inhibit over-activation of TLRs, which are implicated in diverse
pathological conditions. IMO-8400, an antagonist of Toll-like receptors
7, 8, and 9, is currently being evaluated in a clinical proof-of-concept
study in moderate-to-severe plaque psoriasis. Idera continues to
consider additional orphan autoimmune disease indications, including
graft versus host disease and Sjögren's syndrome, as potential disease
targets for subsequent clinical development of IMO-8400. In addition to
its potential utility in autoimmune diseases, IMO-8400 is in clinical
development for treatment of certain genetically defined forms of B-cell
lymphoma, where the TLR pathway also plays a role in disease progression.
About Polymyositis and Dermatomyositis
Polymyositis and dermatomyositis are autoimmune inflammatory myopathies
that cause inflammation and progressive weakness in muscles.
Polymyositis and dermatomyositis sufferers can develop serious
disabilities, including loss in mobility and difficulty breathing and
swallowing, and have an increased risk of certain cancers.
Dermatomyositis is also accompanied by a purple or red skin rash. There
are an estimated 10,000 polymyositispatients and 67,000
dermatomyositis patientsin the U.S. alone. Both polymyositis
and dermatomyositis have been designated as orphan diseases by
the U.S. Food and Drug Administration (FDA).
About Idera Pharmaceuticals, Inc.
Idera’s proprietary technology involves creating novel nucleic acid
therapeutics designed to inhibit over-activation of Toll-like Receptors
(TLRs). Idera is developing these therapeutics for the treatment of
genetically defined forms of B-cell lymphoma and for autoimmune diseases
with orphan indications. In addition to its TLR programs, Idera is
developing gene silencing oligonucleotides that it has created using its
proprietary technology to inhibit the production of disease-associated
proteins by targeting RNA.
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 Idera’s cash resources will be sufficient to fund the Company’s
continuing operations and the further development of the Company’s
programs into the second half of 2016, and whether Idera will be able to
obtain additional cash resources sufficient to fund the Company’s
operations beyond that time; 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 Idera’s preclinical studies and clinical trials will
commence and will be completed when expected by Idera; 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 Annual Report on Form 10-K for the
year ended December 31, 2013, which important factors are incorporated
herein by reference. Idera disclaims any intention or obligation to
update any forward-looking statements.
Source: Idera Pharmaceuticals, Inc.
Investor Contact:
Stern Investor Relations, Inc.
Sarah
McCabe, 267-909-9237
sarah@sternir.com
