Idera Pharmaceuticals Announces Initiation of Treatment in Phase 2 Clinical Trial of IMO-3100 for Psoriasis
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the treatment
of the first patient in a Phase 2 clinical trial of IMO-3100, the
Company’s lead Toll-like receptor (TLR) inhibitor for the treatment of
autoimmune diseases, in patients with moderate to severe plaque
“With the initiation of a Phase 2 trial for IMO-3100 in psoriasis, we
have achieved another important milestone by having mid-stage clinical
trials underway for proprietary drug candidates targeting TLRs in both
oncology and autoimmune diseases, our two key therapeutic areas of
focus,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive
Officer. "We expect our clinical pipeline in autoimmune diseases will
expand further with the advancement of IMO-8400 for the treatment of
lupus following the anticipated submission of an investigational new
drug (IND) application with the U.S. Food and Drug Administration during
the fourth quarter of 2012. We look forward to achieving additional
near-term milestones, including the completion of a Phase 2 study for
IMO-2055 in head and neck cancer expected during the second quarter of
2012 and completion of the Phase 2 study for IMO-3100 in psoriasis
expected during the first half of 2013.”
IMO-3100 is an immunomodulator that inhibits the activity of TLR7 and
TLR9 and modulates the production of multiple pro-inflammatory
mediators, including TNF-α, INF-α, IL1-β, IP-10, IL-17, and IL-23.
IMO-3100 has demonstrated potent activity in reducing pathologic and
immunologic manifestations in preclinical mouse models of psoriasis. In
Phase 1 studies in healthy subjects, IMO-3100 has been well tolerated at
the doses administered, and has shown target engagement of TLR7 and TLR9.
The Phase 2 trial is a randomized, double-blind, and placebo-controlled
study of IMO-3100 in patients with psoriasis. The trial is designed to
evaluate the safety and markers of efficacy of IMO-3100 as a
monotherapy. In the study, 45 patients with moderate to severe plaque
psoriasis will receive IMO-3100 at 0.16 or 0.32 mg/kg or placebo
(saline) by subcutaneous injection once weekly for four weeks.
Assessments of safety will be performed throughout the treatment and
follow-up periods. Psoriasis intensity will be monitored throughout the
study. Skin biopsies of an active psoriasis plaque will be obtained
prior to treatment and one week after the last treatment, and will be
analyzed by immunohistologic staining for changes in epidermal
thickness, immune cell infiltrates and cytokine expression. This trial
is being conducted at multiple sites in the United States, and skin
biopsies will be analyzed at a central laboratory.
Psoriasis is a systemic immune-mediated disorder, characterized by
inflammatory skin and joint manifestations. The most common form, plaque
psoriasis, appears as raised, red patches covered with a silvery white
buildup of dead skin cells. Psoriasis can occur on any part of the body
and is associated with other serious health conditions, such as
diabetes, heart disease and depression.
Psoriasis is the most prevalent autoimmune disease in the U.S.,
according to the National Psoriasis Foundation, affecting as many as 7.5
About TLRs and Idera’s Pipeline
Toll-like Receptors (TLRs) represent a class of proteins that play a key
role in both inflammation and immunity. Of the 10 human TLRs identified
to date, Idera is focusing on compounds targeted to TLRs 3, 7, 8, and 9,
which are expressed in different cells and serve unique functions. For
example, activation of TLR7 and TLR9 present in certain dendritic cells
and lymphocytes may be useful for the treatment of various types of
cancer by stimulating immunity. In contrast, inhibition of specific TLRs
may be useful in treating autoimmune disorders, such as psoriasis and
lupus, by blocking the production of multiple pro-inflammatory
mediators. Using its chemistry-based approach, Idera is advancing novel
drug candidates to modulate immune response through activation or
inhibition of specific TLRs to treat a broad range of diseases,
including autoimmune diseases and cancer.
In oncology, Idera’s lead product candidate is IMO-2055, which is
designed to activate TLR9. IMO-2055 is the subject of several clinical
trials including a randomized, controlled Phase 2 trial in combination
with Erbitux® as a second-line therapy for patients with recurrent or
metastatic squamous cell carcinoma of the head and neck that have not
been previously treated with Erbitux. This multicenter, international
trial is evaluating the effect of adding IMO-2055 to Erbitux alone in 2nd
line treatment, with a primary endpoint of progression-free survival and
secondary endpoints including RECIST objective response rate. In
addition, crossover of the patients who progress on Erbitux alone is
permitted to the combination arm of IMO-2055 and Erbitux. The crossover
permits assessment of the efficacy (response rate and progression-free
survival) of adding IMO-2055 to Erbitux as a third-line therapy in
patients whose disease is refractory to Erbitux alone. A Phase 1b trial
with IMO-2055 in combination with Tarceva® and Avastin® for the
treatment of non-small cell lung cancer has been completed and top-line
results were announced in the first quarter of 2012. A Phase 1b trial
has been conducted with IMO-2055 in combination with FOLFIRI and Erbitux
in patients with advanced colorectal cancer who have progressed
In autoimmune diseases, Idera is developing inhibitors of TLRs 7, 8, and
9 for the potential treatment of psoriasis, lupus, and other diseases.
Idera’s lead clinical candidate is IMO-3100, an antagonist of TLR7 and
TLR9, which is in Phase 2 development for psoriasis. IMO-8400 is an
antagonist of TLRs 7, 8, and 9. Idera expects to file an IND application
for IMO-8400 during the fourth quarter of 2012. Idera has selected lupus
as the initial disease indication for clinical development of IMO-8400.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals applies its proprietary Toll-like receptor (TLR)
drug discovery platform to create immunomodulatory drug candidates and
has clinical development programs in autoimmune diseases and cancer.
Additionally, Idera has a collaboration with Merck & Co. for the use of
TLR-targeted candidates as vaccine adjuvants. The Company is also
advancing its gene-silencing oligonucleotide (GSO) technology for the
purpose of inhibiting the expression of disease-promoting genes. For
more information, visit http://www.iderapharma.com.
Erbitux® is a registered trademark of ImClone LLC, a wholly-owned
subsidiary of Eli Lilly and Company. Tarceva® is a registered trademark
of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc.
Avastin® is a registered trademark of Genentech, Inc.
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 results
obtained in preclinical studies and early clinical trials such as the
studies and trials referred to 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'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;
whether Idera's cash resources will be sufficient to fund the Company's
operations; 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, 2011 which important factors are incorporated
herein by reference. Idera disclaims any intention or obligation to
update any forward-looking statements.