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|Idera to Provide Update on Programs at Stifel Nicolaus Healthcare Conference|
Company to Highlight Continuing Progress in
Idera’s B-cell lymphoma program leverages an emerging scientific understanding of the central role that Toll-like Receptors (TLRs) 7 and 9 play in several forms of B-cell lymphoma with specific mutations, including activated B-cell-like diffuse large B-cell lymphoma (ABC-DLBCL), Waldenström’s macroglobulinemia, and others. The company’s proprietary TLR antagonists have been shown to effectively inhibit TLR 7 and 9 in preclinical studies and in a completed Phase 2 clinical proof-of-concept study in psoriasis.
Existing safety data on IMO-8400 would enable Idera to submit an IND for IMO-8400 in Q4 2013, and initiate a Phase 1/2 clinical trial of IMO-8400 in lymphoma patients with these specific mutations in Q1 2014. The company is currently considering its options for financing this program, and would begin clinical development following the successful completion of these plans.
“We are making rapid progress in turning emerging findings in certain forms of B-cell lymphoma into a clinical development program, and hope to begin dosing the first patients early next year,” Dr. Agrawal said. “Despite notable advances, success in treating B-cell lymphoma has been limited, and patients with certain genetically defined mutations remain in desperate need of new treatments. We believe the limited number and severe condition of these patients may support regulatory designations that would allow us to advance these programs rapidly.”
Idera also will provide an update on its strategy for its autoimmune program at the conference. Idera plans to prioritize orphan indications it could develop itself while developing programs in psoriasis and other large indications through collaborations with larger companies. Idera is developing additional TLR antagonist compounds for use in psoriasis and other autoimmune diseases, with the goal of offering patients a new therapeutic option that could address the shortcomings of currently available biologics by providing improved safety, tolerability and disease remission.
The company expects to complete enrollment in its ongoing Phase 2 trial of IMO-8400 for moderate-to-severe psoriasis this month, and to have top-line data available in the first quarter of 2014. To date, IMO-8400 has been well tolerated in the trial, with no treatment-related discontinuations. Idera believes that TLR antagonists can address an important need in the psoriasis treatment continuum by offering an additional option to be used before progression to biologics.
“The Idera team has significantly strengthened the company by advancing
our lead clinical program, moving quickly to develop a tightly focused
program in lymphoma, and accelerating its efforts to expand our
Forward Looking Statements
Idera Pharmaceuticals, Inc.