Idera Reports Top-Line Trial Data For IMO-8400 In Psoriasis
Idera Pharmaceuticals Inc. announced positive, top-line data from the Phase II trial evaluating its investigational drug IMO-8400 in patients with moderate to severe plaque psoriasis.
The placebo-controlled, double-blind Phase II trial met its primary objective of tolerability profile with no serious adverse events. The trial, which involved 32 patients, also met its secondary endpoints of demonstrating clinical activity against psoriasis as assessed by the Psoriasis Area and Severity Index (PASI).
Sudhir Agrawal, CEO of Idera Pharmaceuticals, said, “Successful completion of this trial is an important additional milestone in our TLR antagonist program. We have studied psoriasis as the initial disease indication to demonstrate clinical proof-of-concept for our TLR antagonists in autoimmune diseases. With these data, we can now pursue our announced business strategy and advance our TLR antagonist drug candidates for the treatment of orphan diseases with high unmet medical need. Towards this goal, our clinical development strategy for IMO-8400 is focused on B-cell lymphomas harboring the MYD88 L265P mutation, and on orphan autoimmune disease indications.”
Plaque psoriasis is the most common form of psoriasis. The disease is a chronic, relapsing, inflammatory skin disorder with a strong basis and origin in genes. Plaque psoriasis is seldom life threatening but is typically resistant to treatment. IMO-8400 is an antagonist of Toll-like receptors (TLRs) 7, 8, and 9. The drug, which is Idera’s lead clinical candidate, is being developed to treat genetically defined forms of B-cell lymphoma and orphan autoimmune diseases. The company said it plans to begin enrollment of patients in further trials for IMO-8400 for Waldenström’s macroglobulinemia, diffuse large B-cell lymphoma and polymyositis, and dermatomyositis.
Lou Brenner, SVP and CMO of Idera Pharmaceuticals, said, “We are very pleased to have met the goals of this trial related to safety and tolerability over three months of dosing, and to have obtained evidence of clinical activity with IMO-8400 in psoriasis patients. This provides further validation of the scientific rationale of blocking over-activation of specific TLRs. These data also support our clinical development plans for IMO-8400 in genetically defined forms of B-cell lymphoma and orphan autoimmune diseases.”