Idera Pharmaceuticals Announces Initiation of Phase 2 Clinical Trial of IMO-8400 in Patients with Dermatomyositis
November 09 2015 - 8:00AM
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company developing Toll-like receptor (TLR) and
RNA therapeutics for patients with cancer and rare diseases, today
announced that the company has commenced enrollment in a Phase 2
clinical trial of IMO-8400, an investigational TLR 7, 8 and 9
antagonist, in patients with dermatomyositis. Dermatomyositis
is a rare and debilitating inflammatory muscle and skin disease
associated with significant morbidity, decreased quality of life
and an increased risk of premature death.
“We are very pleased to initiate this clinical trial for
patients living with dermatomyositis,” stated Kate Haviland,
Idera’s Vice President of Rare Diseases. “Based on
preclinical and clinical studies demonstrating the role of
Toll-like receptors in dermatomyositis and other immune-mediated
inflammatory diseases, we believe IMO-8400 has the potential to
play an important role in the treatment of this serious disease. In
partnership with leading global myositis experts, we carefully
designed this new Phase 2 trial in dermatomyositis to define the
safety and efficacy profile of IMO-8400, as well as contribute data
that will advance the myositis community’s understanding of the
disease.”
“The myositis community is excited by the start of this
important clinical trial,” said Bob Goldberg, Executive Director of
The Myositis Association. “Dermatomyositis is a severe and
disabling disease that can limit the ability of patients to perform
activities of daily living, maintain employment and lead full
independent lives. For many patients, currently available
treatments do not effectively control their disease and/or are not
well tolerated. New targeted therapies such as IMO-8400 will
hopefully improve patient outcomes.”
The Phase 2, randomized, double-blind, placebo-controlled
clinical trial is designed to assess the safety, tolerability and
treatment effect of IMO-8400 in adult patients with
dermatomyositis. Eligibility criteria include evidence of
active skin and muscle involvement. Once enrolled, patients will be
randomized to 1 of 4 groups to receive once weekly subcutaneous
injections of: placebo, or 0.06 mg/kg, 0.2 mg/kg, or 0.6
mg/kg of IMO-8400 for a period of 24 weeks. The study is
expected to enroll approximately 48 patients and is being conducted
at approximately 20 centers in the United States and United
Kingdom. The primary efficacy endpoint is the change from baseline
in the Cutaneous Dermatomyositis Disease Area and Severity Index
(CDASI), a validated outcome measure of skin disease. Additional
exploratory endpoints include muscle strength and function, the
International Myositis Assessment & Clinical Studies Group
(IMACS) core set measures, patient-reported quality of life and
biochemical markers of disease activity.
About Dermatomyositis
Dermatomyositis is a rare, debilitating, inflammatory muscle and
skin disease associated with significant morbidity, decreased
quality of life and an increased risk of premature death. While the
cause of dermatomyositis is not well understood, the disease
process involves immune system attacks against muscle and skin that
lead to inflammation and tissue damage. Major symptoms can include
progressive muscle weakness, severe skin rash, calcium deposits
under the skin (calcinosis), difficulty swallowing (dysphagia) and
interstitial lung disease. Dermatomyositis affects approximately
25,000 people in the United States, and is about twice as common in
women as men, with a typical age of onset between 45 and 65 years
in adults. Dermatomyositis represents one form of myositis, a
spectrum of inflammatory muscle diseases that also includes
juvenile dermatomyositis, polymyositis and inclusion body
myositis.
About IMO-8400
Idera’s Toll-like receptor (TLR) antagonist drug candidates have
been created using a proprietary chemistry-based drug discovery
platform. IMO-8400 is a first-in-class synthetic
oligonucleotide-based antagonist of TLRs 7, 8, and 9. In April
2014, Idera presented preclinical data at the American Association
for Cancer Research Annual Meeting from preclinical studies in
which IMO-8400 inhibited the survival and proliferation of human
B-cell lymphoma cells harboring the oncogenic MYD88 L265P genetic
mutation. IMO-8400 also has shown activity in preclinical studies
of several autoimmune diseases. IMO-8400 has been well-tolerated in
a Phase 1 trial in 42 healthy subjects at single and multiple
escalating doses up to 0.6 mg/kg for four weeks, and has shown
inhibition of immune responses mediated by TLRs 7, 8, and 9. In
2015, Idera announced data from a Phase 2 trial that showed
evidence of clinical activity in patients with psoriasis who were
treated with IMO-8400 at doses of up to 0.6 mg/kg/week for 12
weeks. Idera is pursuing clinical development of IMO-8400 in
genetically defined forms of B-cell lymphoma, including
Waldenström’s macroglobulinemia and diffuse large B-cell lymphoma
harboring the MYD88 L265P mutation, and in rare immune-mediated
inflammatory diseases.
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 third generation antisense 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, including statements about potential treatments for
dermatomyositis. Such statements may be identified by words such as
"believe," "expect," "may," "plan," "potential," "will" and similar
expressions, and are based on the company’s current beliefs and
expectations. Development of drug therapies involves a high degree
of risk, and only a small percentage of research and development
programs undertaken may result in the commercialization of a
product. Positive preclinical data does not ensure that later stage
clinical trials will be successful. There can be no assurance that
the clinical trial referred to herein will achieve the stated
objectives or that administration of IMO-8400 will prove to have
any clinical benefit whatsoever. For more detailed
information on the risks and uncertainties associated with Idera’s
development activities, please review the Risk Factors section of
Idera's most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking
statements speak only as of the date of this press release and the
company assumes no obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
484‐639‐7235
rdoody@iderapharma.com
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