Idera Reports Clinical Hold on Proposed Phase 2 Clinical Trial of IMO-3100
Posted: 20 July 2011 | | No comments yet
Idera Pharmaceuticals announced the receipt of a verbal communication from the U.S. FDA that a proposed Phase 2 protocol…
Idera Pharmaceuticals (Nasdaq: IDRA) today announced the receipt of a verbal communication from the U.S. Food and Drug Administration (FDA) that a proposed Phase 2 protocol that the Company had recently submitted under an Investigational New Drug Application for IMO-3100 will be placed on a clinical hold. The proposed Phase 2 trial of IMO-3100 is for the treatment of psoriasis. A clinical hold is an order issued by the FDA to the sponsor of a clinical trial to delay a proposed clinical trial or suspend an ongoing clinical trial. IMO-3100 is a TLR7 and TLR9 antagonist being developed for the treatment of autoimmune diseases.
The Company has not yet received a written communication from the FDA regarding the clinical hold. Once the Company has received the FDA’s official communication, it will review the content and determine its next steps.
The Company has completed two Phase 1 clinical trials of IMO-3100 in healthy subjects, including an escalating single-dose study and a multiple-dose study. In these studies IMO-3100 was well tolerated and target engagement of TLR7 and TLR9 was observed.
About IMO-3100
IMO-3100, an antagonist of TLR7 and TLR9, is a lead clinical candidate in development to treat autoimmune and inflammatory diseases. IMO-3100 is designed to block production of multiple cytokines induced through TLR7 and TLR9. In contrast, many current autoimmune disease treatments aim to block the activity of individual cytokines. IMO-3100 has demonstrated potent activity in reducing pathologic and immunologic manifestations in preclinical mouse models of diseases such as lupus, arthritis, psoriasis and hyperlipidemia. Phase 1 clinical trials of IMO-3100, including an escalating single-dose study and a multiple-dose study, have been completed in healthy subjects.
