Idera Pharmaceuticals has received verbal notification from the FDA to proceed with a Phase II clinical trial of IMO-3100 in patients with psoriasis, the company announced.
This approval puts the clinical trial process back in motion for IMO-3100, an antagonist of TLR7 and TLR9 that is engineered to block production of multiple cytokines induced through TLR7 and TLR9. The approval process was halted on the drug in July 2011, when the FDA put a 12-week trial of IMO-3100 on hold. The new clinical trial that has received verbal notification to proceed is a 4-week treatment period.
IMO-3100 is in clinical development as a potential therapy for inflammatory and autoimmune diseases. According to Idera, many current autoimmune disease treatments aim to block the activity of individual cytokines, which is where IMO-3100 differs, as it aims to block the activity of two cytokines. In Phase I clinical trials of IMO-3100 in healthy patients, escalating single and multiple doeses of IMO-3100 demonstrated potent activity in reducing pathologic and immunologic manifestations in preclinical mouse models of diseases such as lupus, arthritis, psoriasis and hyperlipidemia, according to Idera.
“We are now preparing for this Phase II trial of our novel dual-TLR antagonist for the treatment of autoimmune diseases and expect to initiate the study in the first half of 2012,” said Sudhir Agrawal, D.Phil., chairman and chief executive officer of Idera.
