CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 5, 2013--
Idera Pharmaceuticals (NASDAQ: IDRA) today announced that it has
initiated dosing in a randomized, double-blind, placebo-controlled Phase
2 trial of IMO-8400 in patients with moderate to severe plaque
psoriasis. IMO-8400, an antagonist of the Toll-like receptors (TLRs) 7,
8, and 9, is a lead clinical candidate in Idera’s autoimmune disease
program. In a Phase 1 trial involving single escalating doses and
multiple doses, IMO-8400 was well tolerated and inhibited TLRs 7, 8, and
9-mediated immune responses. Data from the Phase 1 study will be
presented at a scientific meeting in June 2013.
"This Phase 2 trial of IMO-8400 will enable us to evaluate over a
12-week treatment period the continued trajectory of Psoriasis Area
Severity Index (PASI) score improvement that we observed in the previous
4-week study of our TLR 7 and 9 antagonist, IMO-3100,” said Robert
Arbeit, M.D., Vice President of Clinical Development at Idera. “We
anticipate top-line data from the Phase 2 trial of IMO-8400 to be
available by the end of 2013.”
“In our proof-of-concept study with IMO-3100 in patients with psoriasis,
we observed PASI score improvement, which correlated with significant
improvement in psoriasis disease-associated gene profile, including
downregulation of the IL-17 pathway. We believe the inclusion of TLR8
activity with IMO-8400 would further enhance the clinical activity
observed with IMO-3100 in patients with psoriasis,” said Sudhir Agrawal,
D.Phil., Chairman and Chief Executive Officer of Idera. “We expect that
data from the present Phase 2 trial will help inform our decision on
further development of IMO-8400 in patients with psoriasis. In addition,
during the fourth quarter of 2013, we expect to be in a position to
initiate Phase 2 clinical trials in additional autoimmune disease
indications, including lupus.”
About the 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 12.5 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. The trial is being conducted in the Netherlands.
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
induces 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. In a Phase 1 trial involving single escalating
doses and multiple doses, IMO-8400 was well tolerated and inhibited TLRs
7, 8, and 9-mediated immune responses. A proof-of-concept Phase 2 study
of TLR antagonism in patients with psoriasis using Idera’s antagonist of
TLRs 7 and 9, 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 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 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.
Source: Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com