Company to Highlight Continuing Progress in Autoimmune Development,
Planned Clinical Development Program in Genetically Defined Forms of
B-cell Lymphoma
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 12, 2013--
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today will provide a further
update on its autoimmune program, and its plans for initiating clinical
development in genetically defined forms of B-cell lymphoma, in a
presentation at the Stifel Nicolaus 2013 Healthcare Conference in Boston.
Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera
Pharmaceuticals, and Jim Geraghty, Chairman of Idera’s Board of
Directors, will highlight several ways in which the company has recently
strengthened its business. They will provide an update on progress in
the company's ongoing Phase 2 trial of its lead candidate, IMO-8400, a
TLR 7, 8 and 9 antagonist, present the path forward for the company’s
recently announced B-cell lymphoma program, and describe the company’s
plans to expand its pipeline with the development of additional
preclinical compounds.
Idera’s B-cell lymphoma program leverages an emerging scientific
understanding of the central role that Toll-like Receptors (TLRs) 7 and
9 play in several forms of B-cell lymphoma with specific mutations,
including activated B-cell-like diffuse large B-cell lymphoma
(ABC-DLBCL), Waldenström’s macroglobulinemia, and others. The company’s
proprietary TLR antagonists have been shown to effectively inhibit TLR 7
and 9 in preclinical studies and in a completed Phase 2 clinical
proof-of-concept study in psoriasis.
Existing safety data on IMO-8400 would enable Idera to submit an IND for
IMO-8400 in Q4 2013, and initiate a Phase 1/2 clinical trial of IMO-8400
in lymphoma patients with these specific mutations in Q1 2014. The
company is currently considering its options for financing this program,
and would begin clinical development following the successful completion
of these plans.
“We are making rapid progress in turning emerging findings in certain
forms of B-cell lymphoma into a clinical development program, and hope
to begin dosing the first patients early next year,” Dr. Agrawal said.
“Despite notable advances, success in treating B-cell lymphoma has been
limited, and patients with certain genetically defined mutations remain
in desperate need of new treatments. We believe the limited number and
severe condition of these patients may support regulatory designations
that would allow us to advance these programs rapidly.”
Idera also will provide an update on its strategy for its autoimmune
program at the conference. Idera plans to prioritize orphan indications
it could develop itself while developing programs in psoriasis and other
large indications through collaborations with larger companies. Idera is
developing additional TLR antagonist compounds for use in psoriasis and
other autoimmune diseases, with the goal of offering patients a new
therapeutic option that could address the shortcomings of currently
available biologics by providing improved safety, tolerability and
disease remission.
The company expects to complete enrollment in its ongoing Phase 2 trial
of IMO-8400 for moderate-to-severe psoriasis this month, and to have
top-line data available in the first quarter of 2014. To date, IMO-8400
has been well tolerated in the trial, with no treatment-related
discontinuations. Idera believes that TLR antagonists can address an
important need in the psoriasis treatment continuum by offering an
additional option to be used before progression to biologics.
“The Idera team has significantly strengthened the company by advancing
our lead clinical program, moving quickly to develop a tightly focused
program in lymphoma, and accelerating its efforts to expand our
pipeline,” said Jim Geraghty. “As we build on new findings showing the
potential of TLR antagonists in genetically defined forms of B-cell
lymphoma, we're committed to bringing effective therapies to patients
and value to our shareholders."
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals'
technology platform involves creating novel synthetic RNA- and DNA-based
compounds to modulate immune responses. Idera has applied this platform
to develop proprietary Toll-like receptor (TLR) antagonists as
immunomodulatory drug candidates. Toll-like receptor antagonists block
the overactivation of immune factors which can cause a range of
pathological effects. Idera is conducting clinical development of TLR
antagonists in autoimmune and inflammatory diseases, and preclinical
development of their use in certain genetically defined forms of B-cell
lymphoma. More information on Idera is available at iderapharma.com.
Forward Looking Statements
This press release includes
statements concerning Idera Pharmaceuticals, Inc. and its future
expectations, plans and prospects that constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995 and 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
programs, including the planned Phase 1/2 trial, and whether Idera can
obtain needed resources on a timely basis or at all; whether results
obtained in early research, preclinical studies and clinical trials will
be indicative of the results that will be generated in future
preclinical and clinical studies; 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 enter into collaborations that will advance the development of its
compounds for autoimmune disease indications; 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 June 30, 2013. 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
