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 forward-looking statements.
