Company Completed Phase 1 Trial in
Healthy Subjects Which Demonstrated IMO-9200 Safe and
Well-tolerated Across All Dose Regimens
Pre-Clinical Data Supporting IMO-9200 as
an Oral Therapeutic Option to Treat Inflammatory Bowel Disease
Presented at 2015 Digestive Disease Week Conference
Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage
biopharmaceutical company developing toll-like receptor and RNA
therapeutics for patients with cancer and rare diseases, today
announced the achievement of key development milestones for its
product candidate IMO-9200, an antagonist of Toll-like receptors
(TLRs) 7, 8 and 9. Specifically, the company today reported
top-line data from a Phase 1 clinical trial of IMO-9200 in healthy
subjects and announced the presentation of new preclinical data for
IMO-9200 in models of inflammatory bowel disease (IBD) at the 2015
Digestive Disease Week Conference (DDW) in Washington, DC.
In the placebo-controlled Phase 1 clinical trial in 30 healthy
subjects, IMO-9200 was administered by subcutaneous injection at
escalating single-dose levels of 0.1, 0.3, and 0.5 mg/kg. In the
multiple dose cohort, a dose of 0.5 mg/kg/week for four weeks was
also evaluated. All dose regimens were well tolerated, with no
serious adverse events related to IMO-9200 treatment reported.
There were no patterns of laboratory or other safety parameters
suggestive of any related adverse treatment effect.
Additionally, new preclinical data for IMO-9200 were presented
on Saturday, May 16 at the 2015 Digestive Disease Week Conference
(DDW). The poster presentation, entitled "Targeting Innate Immune
Receptors to Treat Inflammatory Bowel Disease: Activity of Oral
IMO-9200, an Antagonist of TLRs 7, 8, and 9 in Mouse Models of
Colitis," (Abstract #Sa1757) provided results from two mouse models
of colitis. These results demonstrated the potential of orally
dosed IMO-9200 as a treatment for inflammatory bowel disease (IBD),
which includes Crohn's disease (CD) and ulcerative colitis (UC).
Crohn's disease and UC are severe and debilitating autoimmune
disorders characterized by chronic inflammation in the
gastrointestinal tract. A copy of the poster can be found on
Idera's corporate
website: http://www.iderapharma.com/our-science/key-presentations-and-publications.
Presented data showed orally-delivered IMO-9200 treatment
improved body weight and survival, with corresponding improvements
in colon weight, length and histology, in a TNBS-induced Crohn's
disease model. In addition, data showed that IMO-9200
treatment improved pro-inflammatory cytokine gene expression and
levels in the colon and serum, and restored the TGF-β/SMAD3
signaling pathway. Comparable results for IMO-9200 were
observed in a separate DSS-induced UC model, including a reduction
on the Colitis Disease Activity Index (CDAI).
Collectively, these data demonstrate that TLRs are an important
therapeutic target in IBD, and specific blocking of TLRs 7, 8 and 9
with oral IMO-9200 has the potential to disrupt the autoimmune
cycle, reduce chronic intestinal inflammation, and improve disease
symptoms.
Previously conducted preclinical studies have demonstrated the
activity of IMO-9200 in mouse models of other autoimmune diseases,
including the MRL/lpr model of lupus, the collagen antibody-induced
arthritis model of rheumatoid arthritis, and the IL-23-induced
dermal inflammation model of psoriasis.
"These data demonstrating the potential activity of IMO-9200
delivered either orally or subcutaneously as a novel therapeutic
option for patients suffering from autoimmune diseases are
encouraging and provide strong support for advancement into further
clinical development," stated Vincent Milano, Chief Executive
Officer of Idera Pharmaceuticals. "As we noted at the outset
of this year, the strategic focus of Idera is directed towards
oncology and rare diseases and as such, we are currently reviewing
our various strategic options for the future of the IMO-9200
development program."
About Toll-Like Receptors (TLRs) and Idera's Proprietary
TLR Antagonist Technology Platform
Toll-like receptors (TLRs) play a central role in the innate
immune system and in regulating inflammation, and published data
have implicated TLR dysfunction across a broad range of autoimmune
diseases and genetically defined forms of B-cell lymphoma.
In autoimmune diseases, endogenous nucleic acids released from
damaged or dying cells initiate signaling cascades through TLRs,
inducing multiple cytokines. Subsequent inflammation causes further
damage to the body's own tissues and organs and the release of more
self-nucleic acids. Thus, a pathological amplification cycle is
established, promoting disease progression.
In B-cell lymphomas characterized by the MYD88 L265P genetic
mutation, an oncoprotein is produced that over activates
TLR-initiated signaling, thereby activating transcription factors
that promote the survival and proliferation of tumor cells.
Based on the company's proprietary chemistry-based discovery
platform, Idera designed and developed two synthetic
oligonucleotide-based TLR antagonists, IMO-8400 and IMO-9200. These
clinical-stage candidates have demonstrated activity in multiple
preclinical models of autoimmune disease and cancer, including
psoriasis, lupus, arthritis, and MYD88 L265P-positive B-cell
lymphoma.
About Idera
Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage patient-focused,
biopharmaceutical company developing novel therapeutic approaches
for the treatment of cancer and rare diseases. Idera's proprietary
technology involves creating novel nucleic acid therapeutics.
Idera's immunotherapy approach is based on the modulation of
Toll-like receptors (TLRs). In addition to its TLR modulation
programs, Idera is developing gene silencing oligonucleotides (GSO)
technology that it has created to inhibit the production of
disease-associated proteins by targeting RNA. To learn more about
Idera, visit www.iderapharma.com.
Forward- Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements, other than statements of historical fact,
included or incorporated in this press release, including
statements regarding the company's strategy, future operations,
collaborations, intellectual property, prospects, plans, and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," "continue," "will," and "would" and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Idera cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the company's
forward-looking statements. There are a number of important factors
that could cause Idera's actual results to differ materially from
those indicated or implied by its forward-looking statements.
Factors that may cause such a difference include: whether results
obtained in preclinical studies and clinical trials such as the
results described in this release with respect to IMO-9200 will be
indicative of the results that will be generated in future clinical
trials; whether products based on Idera's technology will advance
into or through the clinical trial process when anticipated or at
all or warrant submission for regulatory approval; whether such
products will receive approval from the U.S. 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
collaborations will be successful; and such other important factors
as are set forth under the caption "Risk Factors" in the company's
Quarterly Report on Form 10-Q for the period ended March 31, 2015.
Although Idera may elect to do so at some point in the future, the
company does not assume any obligation to update any
forward-looking statements and it disclaims any intention or
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or
otherwise.
CONTACT: Investor and Media Contact
Robert Doody
Vice President, Investor Relations and
Corporate Communications
484-639-7235
rdoody@iderapharma.com
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