Idera Announces Clinical Development Progress in Its Autoimmune Diseases
CAMBRIDGE, Mass. -- April 1, 2013
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced that it has
completed dosing in its Phase 1 trial of IMO-8400 in healthy subjects. In
addition, the Company announced that its protocol for a Phase 2 study of
IMO-8400 in patients with psoriasis has received “no objection” clearance from
the Competent Authority of the Netherlands. IMO-8400 is an antagonist of
Toll-like receptors (TLRs) 7, 8 and 9, and is in clinical development for the
treatment of autoimmune diseases.
During the first quarter of 2013, the Company completed the escalating
single-dose portion of the Phase 1 trial of IMO-8400 and has now completed
patient dosing in the multiple-dose portion of the trial. The multiple-dose
portion of the trial involved two dose levels of IMO-8400, 0.3 and 0.6 mg/kg,
and placebo, with six subjects receiving each treatment of four weekly doses.
The Company expects to report top-line data from the multiple-dose portion of
the trial later in the second quarter of 2013.
The Company also announced that the protocol that it has submitted for a Phase
2 trial of IMO-8400 in patients with psoriasis has received “no objection”
clearance from the Competent Authority of the Netherlands. Under the protocol
for this trial, 32 patients would be randomized to receive weekly doses for up
to 12 weeks at one of three dose levels or placebo. The Company does not plan
to commence this trial until it has reviewed the results from the Phase 1
trial of IMO-8400 and obtained the resources to fund the Phase 2 trial.
“We have made steady progress in advancing IMO-8400 in our autoimmune disease
program,” said Robert Arbeit, M.D., VP of Clinical Development at Idera. “We
have completed four-week dosing of IMO-8400 at two dose levels in healthy
subjects, and are now in position to progress to a Phase 2 trial. We are
pleased to have regulatory clearance of our Phase 2 protocol in patients with
moderate-to-severe plaque psoriasis.”
The Company further announced that an analysis of biopsy samples from its
previous Phase 2 trial of IMO-3100 in patients with psoriasis has been
conducted by James G. Krueger, M.D., Ph.D, of The Rockefeller University. In
these samples, the Company observed a gene expression profile that is
consistent with treatment-related improvement in psoriasis disease-associated
genes, including the IL-17 pathway.
“Top-line microarray results of the clinical samples show significant
improvement of psoriasis disease-associated gene profile in patients treated
with IMO-3100 compared to placebo,” said Dr. Krueger. “Importantly, the IL-17
pathway, which is central to the pathogenesis of psoriasis, was down-regulated
in samples from treated patients.”
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of
autoimmune and inflammatory diseases by targeting specific Toll-like Receptors
(TLRs) to inhibit the induction of immune responses. The Company has two drug
candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and
9, and IMO-3100, an antagonist of TLR7 and 9. Additionally, Idera has a
collaboration with Merck & Co. for the use of TLR agonists as vaccine
adjuvants for cancer, infectious diseases and Alzheimer’s disease. 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 development of the Company’s
autoimmune disease program; whether results obtained in preclinical studies
and early clinical trials 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 Annual Report on Form 10-K for the
year ended December 31, 2012 which important factors are incorporated herein
by reference. Idera disclaims any intention or obligation to update any
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
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