CAMBRIDGE, MA, USA I April 1, 2013 I Idera Pharmaceuticals, Inc. (IDRA) today announced that it has completed dosing in its Phase 1 trial of IMO-8400 in healthy subjects. In addition, the Company announced that its protocol for a Phase 2 study of IMO-8400 in patients with psoriasis has received “no objection” clearance from the Competent Authority of the Netherlands. IMO-8400 is an antagonist of Toll-like receptors (TLRs) 7, 8 and 9, and is in clinical development for the treatment of autoimmune diseases.
During the first quarter of 2013, the Company completed the escalating single-dose portion of the Phase 1 trial of IMO-8400 and has now completed patient dosing in the multiple-dose portion of the trial. The multiple-dose portion of the trial involved two dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects receiving each treatment of four weekly doses. The Company expects to report top-line data from the multiple-dose portion of the trial later in the second quarter of 2013.
The Company also announced that the protocol that it has submitted for a Phase 2 trial of IMO-8400 in patients with psoriasis has received “no objection” clearance from the Competent Authority of the Netherlands. Under the protocol for this trial, 32 patients would be randomized to receive weekly doses for up to 12 weeks at one of three dose levels or placebo. The Company does not plan to commence this trial until it has reviewed the results from the Phase 1 trial of IMO-8400 and obtained the resources to fund the Phase 2 trial.
“We have made steady progress in advancing IMO-8400 in our autoimmune disease program,” said Robert Arbeit, M.D., VP of Clinical Development at Idera. “We have completed four-week dosing of IMO-8400 at two dose levels in healthy subjects, and are now in position to progress to a Phase 2 trial. We are pleased to have regulatory clearance of our Phase 2 protocol in patients with moderate-to-severe plaque psoriasis.”
The Company further announced that an analysis of biopsy samples from its previous Phase 2 trial of IMO-3100 in patients with psoriasis has been conducted by James G. Krueger, M.D., Ph.D, of The Rockefeller University. In these samples, the Company observed a gene expression profile that is consistent with treatment-related improvement in psoriasis disease-associated genes, including the IL-17 pathway.
“Top-line microarray results of the clinical samples show significant improvement of psoriasis disease-associated gene profile in patients treated with IMO-3100 compared to placebo,” said Dr. Krueger. “Importantly, the IL-17 pathway, which is central to the pathogenesis of psoriasis, was down-regulated in samples from treated patients.”
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of autoimmune and inflammatory diseases by targeting specific Toll-like Receptors (TLRs) to inhibit the induction of immune responses. The Company has two drug candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and 9, and IMO-3100, an antagonist of TLR7 and 9. Additionally, Idera has a collaboration with Merck & Co. for the use of TLR agonists as vaccine adjuvants for cancer, infectious diseases and Alzheimer’s disease. For more information, visit http://www.iderapharma.com.
SOURCE: Idera Pharmaceuticals
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CAMBRIDGE, MA, USA I April 1, 2013 I Idera Pharmaceuticals, Inc. (IDRA) today announced that it has completed dosing in its Phase 1 trial of IMO-8400 in healthy subjects. In addition, the Company announced that its protocol for a Phase 2 study of IMO-8400 in patients with psoriasis has received “no objection” clearance from the Competent Authority of the Netherlands. IMO-8400 is an antagonist of Toll-like receptors (TLRs) 7, 8 and 9, and is in clinical development for the treatment of autoimmune diseases.
During the first quarter of 2013, the Company completed the escalating single-dose portion of the Phase 1 trial of IMO-8400 and has now completed patient dosing in the multiple-dose portion of the trial. The multiple-dose portion of the trial involved two dose levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects receiving each treatment of four weekly doses. The Company expects to report top-line data from the multiple-dose portion of the trial later in the second quarter of 2013.
The Company also announced that the protocol that it has submitted for a Phase 2 trial of IMO-8400 in patients with psoriasis has received “no objection” clearance from the Competent Authority of the Netherlands. Under the protocol for this trial, 32 patients would be randomized to receive weekly doses for up to 12 weeks at one of three dose levels or placebo. The Company does not plan to commence this trial until it has reviewed the results from the Phase 1 trial of IMO-8400 and obtained the resources to fund the Phase 2 trial.
“We have made steady progress in advancing IMO-8400 in our autoimmune disease program,” said Robert Arbeit, M.D., VP of Clinical Development at Idera. “We have completed four-week dosing of IMO-8400 at two dose levels in healthy subjects, and are now in position to progress to a Phase 2 trial. We are pleased to have regulatory clearance of our Phase 2 protocol in patients with moderate-to-severe plaque psoriasis.”
The Company further announced that an analysis of biopsy samples from its previous Phase 2 trial of IMO-3100 in patients with psoriasis has been conducted by James G. Krueger, M.D., Ph.D, of The Rockefeller University. In these samples, the Company observed a gene expression profile that is consistent with treatment-related improvement in psoriasis disease-associated genes, including the IL-17 pathway.
“Top-line microarray results of the clinical samples show significant improvement of psoriasis disease-associated gene profile in patients treated with IMO-3100 compared to placebo,” said Dr. Krueger. “Importantly, the IL-17 pathway, which is central to the pathogenesis of psoriasis, was down-regulated in samples from treated patients.”
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of autoimmune and inflammatory diseases by targeting specific Toll-like Receptors (TLRs) to inhibit the induction of immune responses. The Company has two drug candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and 9, and IMO-3100, an antagonist of TLR7 and 9. Additionally, Idera has a collaboration with Merck & Co. for the use of TLR agonists as vaccine adjuvants for cancer, infectious diseases and Alzheimer’s disease. For more information, visit http://www.iderapharma.com.
SOURCE: Idera Pharmaceuticals
Post Views: 327
