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Idera Pharmaceuticals Announces Results of Phase 1 Clinical Trial of IMO-8400, Toll-like Receptor Antagonist Drug Candidate for

  Idera Pharmaceuticals Announces Results of Phase 1 Clinical Trial of
  IMO-8400, Toll-like Receptor Antagonist Drug Candidate for Autoimmune and
  Inflammatory Diseases

               IMO-8400 Demonstrates Favorable Safety Profile

Sustained Inhibition of Targeted TLR 7-, 8-, and 9-mediated Cytokine Induction
                                   Observed

Phase 2 Trial of IMO-8400 in Patients with Moderate-to-Severe Plaque Psoriasis
                                   Ongoing

Business Wire

CAMBRIDGE, Mass. -- July 1, 2013

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced results of a Phase 1
clinical trial of IMO-8400, a first-in-class antagonist of Toll-like Receptors
(TLRs) 7, 8, and 9 being developed for potential applications in autoimmune
and inflammatory diseases. In this trial, IMO-8400 was administered at single
escalating dose levels and multiple dose levels weekly for four weeks in
healthy subjects. IMO-8400 was well tolerated at all dose levels.
IMO-8400-treated subjects showed inhibition of TLR 7-, 8-, and 9-mediated
cytokines, including tumor necrosis factor-alpha (TNF-α), interleukin-1 beta
(IL-1β), interleukin-6 (IL-6), interferon-alpha (IFN-α), and other
pro-inflammatory cytokines. These results were presented at the 13th Annual
Meeting of the Federation of Clinical Immunology Societies (FOCIS), held on
June 27-30, 2013, in Boston, MA.

"We are very pleased with the safety and tolerability of IMO-8400 in this
trial. Further, IMO-8400 showed strong and sustained inhibition of TLR7-, 8-,
and 9- mediated cytokine induction," said Robert D. Arbeit, M.D., Vice
President of Clinical Development. "Based on these encouraging results, we
have initiated a randomized, double-blind, placebo-controlled Phase 2 trial of
IMO-8400 in patients with psoriasis to evaluate PASI score improvement over a
12-week treatment period at three dose levels."

“We anticipate data from the ongoing Phase 2 trial to be available by
year-end. Results from this study will inform our decisions regarding later
stage clinical development of IMO-8400 in patients with psoriasis and clinical
development in other indications,” said Sudhir Agrawal, D.Phil., Chairman and
Chief Executive Officer. “IMO-8400 has potential applications in a broad range
of autoimmune and inflammatory diseases, in which TLRs 7, 8, and 9 are
implicated in exacerbating the disease.”

Phase 1 Clinical Trial Results

  *IMO-8400 was well tolerated in single- and multiple-dose regimens at all
    dosages
  *The intended pharmacodynamic mechanism of action was demonstrated in
    IMO-8400 treated subjects
  *Cytokine induction mediated by TLRs 7, 8, and 9 was inhibited in IMO-8400
    treated subjects and not in placebo treated subjects
  *The induction of multiple cytokines was inhibited, including TNF-α, IL-1β,
    IL-6 and IFN-α
  *Inhibition of cytokine induction was sustained for seven days after dosing
    with IMO-8400
  *Pharmacokinetics showed IMO-8400 was rapidly cleared from plasma with no
    accumulation
  *Pharmacodynamic results support a weekly dose regimen for evaluation of
    IMO-8400 in clinical development in autoimmune disease indications

About the IMO-8400 Phase 1 Trial in Healthy Subjects

A Phase 1 clinical trial of IMO-8400 was conducted to assess the safety,
pharmacokinetic and pharmacodynamic activity in healthy subjects. This
randomized, double-blind, placebo controlled trial enrolled 42 healthy
subjects. The single-dose portion of the trial involved three escalating dose
levels of 0.1, 0.3 and 0.6 mg/kg of IMO-8400 or placebo, with six subjects
receiving each treatment. The multiple-dose portion of this trial involved two
dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects
receiving each treatment for four weekly doses. Safety and tolerability were
monitored throughout the study. Pharmacokinetic activity and pharmacodynamic
activity were monitored at specific times.

About the Ongoing IMO-8400 Phase 2 Trial in Patients with Moderate to Severe
Plaque Psoriasis

The Phase 2 trial is a randomized, double-blind, placebo-controlled trial of
IMO-8400 monotherapy in patients with moderate to severe plaque psoriasis. In
this trial, 32 patients with PASI scores of 12.0 or greater will be randomized
1:1:1:1 to receive weekly subcutaneous doses of IMO-8400 at 0.075, 0.15, or
0.3 mg/kg/week or placebo for 12 weeks. Safety and improvements in PASI score
will be monitored throughout the trial.

About TLRs and Idera's Pipeline

Toll-like Receptors (TLRs) play a key role in immunity and inflammation. Using
a chemistry-based approach, Idera has created compounds targeted to endosomal
TLRs 3, 7, 8, and 9. In autoimmune diseases, immune complexes containing host
DNA/RNA activate TLRs 7, 8, and 9, which induce multiple cytokines that
further exacerbate the disease. Inhibition of these TLRs is a novel approach
for the potential treatment of autoimmune diseases. IMO-8400 is an antagonist
of TLRs 7, 8, and 9, and has shown therapeutic activity in preclinical models
of psoriasis, lupus, and arthritis. Our proof-of-concept Phase 2 trial of TLR
antagonism in patients with psoriasis using a TLR7 and 9 antagonist, IMO-3100,
showed PASI score improvements which correlated with significant improvement
in psoriasis disease associated gene profile, including downregulation of the
IL-17 pathway.

About Idera Pharmaceuticals, Inc.

Idera Pharmaceuticals applies its proprietary Toll-like receptor (TLR) drug
discovery platform to create immunomodulatory drug candidates and is
conducting clinical development in autoimmune and inflammatory diseases.
Additionally, Idera has a collaboration with Merck & Co. for the use of
TLR-targeted candidates as vaccine adjuvants. 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 including the additional clinical trials of
IMO-8400 referred to in this release; whether results obtained in preclinical
studies and early clinical trials such as the results described 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;
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 March
31, 2013 which important factors are incorporated herein by reference. Idera
disclaims any intention or obligation to update any forward-looking
statements.

Contact:

Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com
 
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