Idera announces Phase I progress in autoimmune diseases program

Idera Pharmaceuticals, Inc., a Cambridge, Massachusetts-based clinical-stage pharmaceutical company, announced on Monday that it completed dosing in its Phase I trial of a drug meant to target specific toll-like receptors to inhibit immune responses.

IMO-8400, a drug candidate that acts as an antagonist of TLRs 7, 8 and 9, is in clinical development for the treatment of autoimmune diseases. The company previously completed the escalating single-dose portion of the trial and recently completed patient dosing in the trial's multiple-dose portion. The trial involved two dose levels of IMO-8400 and a placebo. Idera expects to report top-line data from the multiple-dose portion of the trial in 2013's second quarter.

Idera also announced the Competent Authority of the Netherlands gave a Phase II trial of IMO-8400 no objection clearance. In the trial, 32 patients would receive either weekly doses of one of three dose levels or a placebo for up to 12 weeks. Idera plans to commence the trial after it receives results from the Phase I trial and funding for the Phase II trial.

"We have made steady progress in advancing IMO-8400 in our autoimmune disease program," Robert Arbeit, Idera's vice president of clinical development, said. "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 II trial. We are pleased to have regulatory clearance of our Phase II protocol in patients with moderate-to-severe plaque psoriasis."

Additionally, James Krueger, a scientist with the Rockefeller University, conducted an analysis of biopsy samples from Idera's previous Phase II trial of IMO-3100 in patients with psoriasis. IMO-3100 is an antagonist of TLR 7 and 9. Idera observed a gene expression profile in the study that is consistent with treatment-related improvement in genes associated with psoriasis, 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," Krueger said. "Importantly, the IL-17 pathway, which is central to the pathogenesis of psoriasis, was down-regulated in samples from treated patients."