Idera Pharmaceuticals, Inc. (IDRA) announced that the FDA has granted orphan drug designation to its lead pipeline candidate, IMO-8400, for the treatment of Waldenström's macroglobulinemia (WM). The candidate is an antagonist of toll-like receptors (TLRs) 7, 8, and 9.
We note that the FDA grants orphan drug designation to candidates being developed to treat rare diseases/disorders that affect less than 200,000 people in the U.S. The status makes the candidate eligible for seven years of marketing exclusivity in the U.S., following approval apart from other benefits.
IMO-8400 is currently in a phase I/II trial for the treatment of WM in patients who have suffered relapses or have failed to respond to one or more prior therapies. The study is evaluating the safety, tolerability and potential clinical activity of the candidate. Idera said that the study’s independent data review committee has finished its review of the four-week safety data from the second dose cohort (1.2 mg/kg/week).
The committee has also given the green signal to open enrolment in the third dose cohort (2.4 mg/kg/week). Idera expects final 24-week safety and clinical activity data from the study in the second half of 2015.
As per the American Cancer Society, 1,000 to 1,500 new patients with WM are diagnosed in the U.S. each year.
Pharmacyclics, Inc. (PCYC) and Johnson & Johnson (JNJ) are also looking to get their oncology product, Imbruvica, approved for the treatment of WM. The drug is under review in the U.S. with a final decision expected by Apr 17, 2015.
Apart from WM, Idera is also studying IMO-8400 in other indications like plaque psoriasis, certain rare genetically defined forms of B-cell lymphoma and rare autoimmune diseases. We expect investor focus to remain on the candidate.
Investors looking for better-ranked stocks in the health care sector may consider Affymetrix Inc. (AFFX) which carries a Zacks Rank #1 (Strong Buy).
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