Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing a novel therapeutic approach for the treatment of autoimmune diseases and genetically defined forms of B-cell lymphoma, today reported financial results for the quarter ended September 30, 2013 and provided a corporate update.
“This has been a highly productive quarter at Idera, both clinically and operationally,” said Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals. “We continued to successfully execute against our stated goals in our autoimmune disease and B-cell lymphoma programs. We submitted an IND for our planned Phase 1/2 trial of IMO-8400 in Waldenström’s macroglobulinemia. In addition, we completed enrollment in our Phase 2 trial of IMO-8400 in patients with moderate-to-severe plaque psoriasis as planned and have expanded the trial to include a higher dose cohort. We also raised over $27 million in a public offering which has further strengthened our financial position and our ability to move forward on our objectives.”
Idera announced today several developments in its ongoing program in autoimmune diseases. In September 2013, Idera completed enrollment of the 32 patients initially planned in the Company’s ongoing randomized, double-blind, placebo-controlled Phase 2 trial of IMO-8400 in patients with moderate-to-severe plaque psoriasis. These 32 patients were randomized for treatment at three dose levels of IMO-8400, 0.075 mg/kg, 0.15 mg/kg and 0.3 mg/kg, and in a placebo cohort. While the dosing in the trial is ongoing, the data remain blinded. All treatments to date have been well tolerated in the trial. Based on this positive safety profile, the Company has expanded the trial to include a higher dose cohort of 0.6 mg/kg and placebo in up to 12 patients. Idera plans to consider further dose escalation based on the safety and tolerability observed in the expansion cohort. The Company expects to report top-line data from the first three dosing groups of the trial in the first quarter of 2014 and to report top-line data from the expansion cohort in the second quarter of 2014.