Category Archives: Transhuman News

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Idera Pharmaceuticals today announced that it had completed patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 trial of IMO-3100 in patients with moderate-to-severe plaque psoriasis. IMO-3100 is an antagonist of specific Toll-like Receptors (TLRs) that the Company is developing for the treatment of psoriasis and other autoimmune diseases. Idera anticipates top-line data from this study will be available by year-end 2012. TLRs are a class of proteins that play a key role in both inflammation and immunity. Through the inhibition of specific TLRs, Ideras candidates may represent a novel approach for the treatment of psoriasis, lupus and other autoimmune diseases.

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 (PGA) scores, said Dr. Robert Arbeit, Vice President of Clinical Development at Idera. In addition to the clinical assessments, we are evaluating biopsies of psoriasis plaques for treatment-related changes in epidermal thickness and immune cell infiltrates consistent with the intended mechanism of action.

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. Sudhir Agrawal, Chief Executive Officer of Idera. In addition, our investigational new drug (IND) application for IMO-8400, a lead candidate for lupus, is now active. We expect our phase 2 study of IMO-3100 and planned clinical trials of IMO-8400 will help us to establish the benefits of inhibiting Toll-like Receptor-mediated pathways, which include controlling the induction of multiple cytokines, such as TNF-, IL-12, IL-6, and IL-17, as well as downstream signaling. We look forward to reporting top-line data from the Phase 2 study of IMO-3100 in psoriasis and initiating clinical development of IMO-8400 before the end of 2012.

Idera also announced today that its Investigational New Drug application for IMO-8400 with the US Food and Drug Administration is now active. IMO-8400, an antagonist of TLRs 7, 8, and 9, is Ideras second lead candidate for use in treating autoimmune diseases, with lupus selected as an initial indication for clinical development. Idera anticipates initiating a Phase 1 dose escalation trial during the fourth quarter of 2012 to evaluate the safety and pharmacodynamics of IMO-8400 in healthy subjects. Following successful completion of the Phase 1 study, Idera expects to initiate a Phase 2 clinical trial of IMO-8400 in patients with lupus.

Recent and Upcoming Autoimmune Disease Program Milestones

Fourth Quarter 2012:

Year 2013:

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.

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Idera Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2 Trial of IMO-3100 in Patients with Psoriasis

ScienceDaily (Oct. 15, 2012) An analysis of 27 studies linking psoriasis in 314,000 individuals with diabetes has found strong correlation between the scaly skin rash and the blood sugar disorder that predisposes patients to heart disease, say UC Davis researchers who led the review.

The findings appear in the Archives of Dermatology.

"Our investigation found a clear association between psoriasis and diabetes," said April Armstrong, assistant professor of dermatology at UC Davis and principal investigator of the study. "Patients with psoriasis and their physicians need to be aware of the increased risk of developing diabetes so that patients can be screened regularly and benefit from early treatment."

Psoriasis is a common skin problem that tends to run in families. It causes a raised red, flaky and sometimes itchy rash, often on the elbows and knees, although it can appear anywhere. It is believed to be an autoimmune disease, in which the body regards its own skin as foreign and mounts an inflammatory response.

Armstrong and her colleagues combined data from 27 observational studies of patients with psoriasis, in what is known as a meta-analysis. Five of the studies assessed the incidence of diabetes -- that is, how many patients with psoriasis developed diabetes during the course of a study, which ranged from 10 to 22 years. The other studies assessed the prevalence of diabetes -- how many patients already had diabetes at the outset of a study. Altogether, the studies evaluated more than 314,000 people with psoriasis and compared them to 3.7 million individuals (controls) without the disease.

Some of the studies classified patients by disease severity. The aggregate data for these studies showed that patients with mild psoriasis are over 1.5 times more likely to have diabetes than the general population while those with severe disease are nearly twice as likely. Among studies that assessed incidence, patients with psoriasis had a 27 percent increased risk of developing diabetes compared with the general population.

All but one study analyzing incidence found a link between psoriasis and diabetes. These studies included patient data from outpatient clinics, insurance claims and hospitals. Diabetes rates were similar in patients despite ethnicity or country where the study was conducted.

"The large sample size and consistent association between psoriasis and diabetes make these study findings very strong and suggest an underlying physiological link between the two diseases," said Armstrong, who directs the Dermatology Clinical Research Unit at UC Davis and the teledermatology program.

While additional research is need to understand how the two diseases are associated, Armstrong believes altered immune pathways may make psoriasis patients more susceptible to developing diabetes.

"There is evidence that fat cells in psoriasis patients may not function normally," she said. "These cells secrete inflammatory substances known as cytokines that increase insulin resistance in the liver and muscle and initiate destruction of insulin-producing cells in the pancreas."

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People with severe psoriasis nearly twice at risk for diabetes