Idera Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2 Trial of IMO-3100 in Patients with Psoriasis
First Human Trial in Lupus Program Anticipated to Begin in 2012
“In this Phase 2 proof-of-concept study, we are evaluating multiple
endpoints to assess the clinical activity of IMO-3100, including the
impact on Psoriasis Area Severity Index (PASI), mean focal psoriasis
severity, and Physician Global Assessment (
“We have made significant progress in advancing our autoimmune disease
program, including the completion of enrollment in the Phase 2 trial of
IMO-3100 in patients with psoriasis.” said Dr.
Idera also announced today that its Investigational New Drug application
for IMO-8400 with the
Recent and Upcoming Autoimmune Disease Program Milestones
Fourth Quarter 2012:
- Complete enrollment in Phase 2 trial of IMO-3100 for the treatment of moderate to severe plaque psoriasis (completed)
-
Submission of Investigational New Drug (IND) application to the
US Food and Drug Administration for IMO-8400 (completed) - Present preclinical data on IMO-8400 at major scientific meetings
- Initiation of Phase 1 trial of IMO-8400
- Report top-line data from the Phase 2 trial of IMO-3100 for the treatment of moderate-to-severe plaque psoriasis
Year 2013:
- Report final data from the Phase 2 trial of IMO-3100 for the treatment of moderate-to-severe plaque psoriasis
- Report data from Phase 1 trial of IMO-8400
- Initiate Phase 2 trial of IMO-8400 in patients with lupus
About TLRs and Idera's Pipeline
Toll-like Receptors (TLRs) play a key role in inflammation and immunity. Of the 10 human TLRs identified to date, Idera is developing compounds targeted to TLRs 3, 7, 8, and 9, which are expressed in different cells and serve unique functions. Using its chemistry-based approach, Idera has created novel drug candidates that modulate immune responses through either activation or inhibition of specific TLRs. Inhibition of specific TLRs may be useful in treating autoimmune disorders, such as systemic lupus erythematosus (SLE), psoriasis, and rheumatoid arthritis, by blocking the induction of multiple cytokines and signaling pathways. Idera's lead clinical candidates for application in autoimmune diseases are IMO-3100, an antagonist of TLR7 and TLR9, and IMO-8400, an antagonist of TLRs 7, 8, and 9.
A characteristic of autoimmune diseases such as SLE and psoriasis is the production of immune complexes with self-nucleic acids. These abnormal immune complexes activate TLRs 7, 8, and 9 and induce multiple cytokines that cause further damage to the body's own tissues and organs, thereby releasing more self-nucleic acids. Thus, a pathologic amplification cycle is established, promoting disease maintenance and progression. In preclinical models of several autoimmune diseases, IMO-3100 and IMO-8400 inhibited TLR-mediated immune responses, broke the cycle of disease maintenance and progression through decreases in Th1, Th17 and inflammasome pathways, and led to improvements in multiple measures of disease.
About the Phase 2 Trial of IMO-3100 in Patients with Moderate to Severe Plaque Psoriasis
The Phase 2 trial is a randomized, double-blind, placebo-controlled
study of IMO-3100 in patients with psoriasis. In the study, 44 patients
with moderate to severe plaque psoriasis were randomized 1:1:1 to
receive IMO-3100 at 0.16 or 0.32 mg/kg or placebo by subcutaneous
injection once weekly for four weeks. Assessments of safety will be
performed throughout the treatment and four-week follow-up periods.
Psoriasis intensity, using Psoriasis Area Severity Index (PASI), mean
focal psoriasis severity and Physician Global Assessment (
About Psoriasis
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
About IMO-3100
IMO-3100, an antagonist of TLR7 and TLR9, is a lead drug candidate in development to treat autoimmune diseases, including psoriasis. In preclinical mouse models of psoriasis, IMO-3100 exerted therapeutic activity by inhibiting disease-associated gene expression and cytokines, such as IL-6, IL-22, IL-17, IL-23, NLRP3, and IL-1β, and proteins in the skin such as S100A7, DEFB4, and LL37. In addition, histological evaluation showed that the psoriatic lesions in IMO-3100 treated animals had reduced epidermal thickness and decreased lymphocyte infiltration compared to control mice.
About IMO-8400
IMO-8400, an antagonist of TLRs 7, 8, and 9, is a lead drug candidate in development to treat autoimmune diseases, with systemic lupus erythematosus (lupus) as the first indication for development. In preclinical mouse models of lupus, treatment with IMO-8400 has led to a reduction in levels of autoimmune antibodies, including anti-DNA, anti-RNA and anti-SM, compared to untreated mice. In addition, improvements in renal function, such as reductions in blood urea nitrogen, proteinuria, and histopathology changes in the kidney, were observed in IMO-8400 treated mice. Treatment of mice with IMO-8400 inhibited multiple disease-associated cytokines and decreased abnormal gene expression patterns compared to untreated mice.
About Systemic Lupus Erythematosus
Lupus is a chronic autoimmune disease where the body's immune system
becomes hyperactive and attacks normal healthy tissue. This results in
symptoms such as inflammation, swelling, and damage to joints and almost
every major organ in the body, including the heart, kidneys, skin, lungs
and brain. According to
About
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
Source:
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com