Idera Pharma: FDA Grants Orphan Drug Designation For IMO-8400 - Quick Facts

(RTTNews) - Idera Pharmaceuticals Inc. (IDRA) announced the U.S. FDA has granted orphan drug designation for IMO-8400, an antagonist of the endosomal Toll-like receptors (TLRs) 7, 8 and 9, for the treatment of Waldenström's macroglobulinemia.

Waldenström's macroglobulinemia is a non-Hodgkin lymphoma of malignant lymphoplasmacytic B-cells that commonly involves the blood and bone marrow and may spread to almost any organ in the body.

Idera also noted that the company is currently conducting a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia, who have a history of relapse or failure to respond to one or more prior therapies. The objectives of the trial are to evaluate the compound's safety, tolerability and potential clinical activity. Final 24-week safety and clinical activity data are anticipated in the second half of 2015.