Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the initiation of dosing in a Phase 1 trial of IMO-8400. IMO-8400 is an antagonist of Toll-like receptors (TLRs) 7, 8 and 9, and is the second clinical candidate in Idera’s autoimmune disease program. Idera expects to develop IMO-8400 for the treatment of lupus as an initial indication. Idera also announced the presentation of preclinical data on IMO-8400 at the American College of Rheumatology that support its potential to treat autoimmune diseases through inhibition of Th1, Th17, and inflammasome activation.
“We are pleased to have initiated the clinical development of IMO-8400 in our lupus program,” said Robert Arbeit, MD, Vice President of Clinical Development at Idera. “IMO-8400 provides a novel approach to the treatment of lupus, by blocking signaling through Toll-like receptors. In preclinical studies, lupus-prone mice treated with IMO-8400 demonstrated suppression of multiple pro-inflammatory cytokines, inhibition of auto-antibody production, and improvement in renal function, all of which are components of SLE pathophysiology. These changes are consistent with the intended mechanism of action of this candidate.”
“The next objectives in our autoimmune disease programs are to have top-line data for some of the endpoints from our Phase 2 trial of IMO-3100 in patients with psoriasis by year end 2012 and to complete our Phase 1 trial of IMO-8400,” said Dr. Sudhir Agrawal, Chief Executive Officer of Idera. “Our recent raise of $7 million, in addition to the $8.5 million that we had on hand at the end of the third quarter, we expect will allow us to meet these near-term objectives.”
The goals of the Phase 1 trial in the clinical development of IMO-8400 are to assess the safety and pharmacodynamic activity of IMO-8400 in healthy subjects. A total of 30 healthy subjects are scheduled to receive single or multiple ascending doses of IMO-8400. Data from this study are expected to be available during Q2 2013. Following successful completion of the Phase 1 study and additional funding, the Company expects to initiate a Phase 2 clinical trial of IMO-8400 in lupus patients.