The company plans to submit a protocol to the US Food and Drug Administration (FDA) in the first half of 2014 for a Phase I/II clinical trial to investigate the safety and potential utility of IMO-8400 in these two indications.
This represents the execution of a previously announced strategy to expand the clinical development of IMO-8400 in orphan autoimmune disease indications. Based on the results from this study, Idera anticipates that it will pursue separate later-stage clinical trials for each indication.
Idera Pharmaceuticals senior vice president and chief medical officer Dr Lou Brenner noted its team of scientists, clinicians, and advisors has prioritized polymyositis and dermatomyositis among a wide range of orphan autoimmune diseases that may potentially benefit from our TLR antagonist program.
"We are excited to explore the potential of IMO-8400 for the treatment of patients with these challenging conditions," Dr Brenner added.
Idera’s toll-like receptor (TLR) antagonist platform is designed to inhibit over-activation of TLRs, which are implicated in diverse pathological conditions. IMO-8400, an antagonist of Toll-like receptors 7, 8, and 9, is currently being evaluated in a clinical proof-of-concept study in moderate-to-severe plaque psoriasis.
Idera continues to consider additional orphan autoimmune disease indications, including graft versus host disease and Sjögren’s syndrome, as potential disease targets for subsequent clinical development of IMO-8400.
In addition to its potential utility in autoimmune diseases, IMO-8400 is in clinical development for treatment of certain genetically defined forms of B-cell lymphoma, where the TLR pathway also plays a role in disease progression.