Idera Pharmaceuticals, Inc. (IDRA) shares jumped 17.78% after the company announced positive top-line data from a phase II study on its lead pipeline candidate, IMO-8400, an antagonist of toll-like receptors (TLRs) 7, 8, and 9.
The randomized, double-blind, placebo controlled phase II study (n = 32) assessed the safety and tolerability (primary objective) of IMO-8400 (at dose levels of 0.075 mg/kg, 0.15 mg/kg and 0.3 mg/kg) versus placebo in patients suffering from moderate-to-severe plaque psoriasis over 12 weeks. The study also evaluated the clinical activity of IMO-8400.
The study met its primary objective as IMO-8400 demonstrated safety and tolerability at all three dose levels. The study also met its secondary objective. In the study, 50% improvement (from the baseline Psoriasis Area and Severity Index/PASI) was observed in 45% of the patients receiving IMO-8400 as compared to 14% in the placebo arm. Higher number of patients showed 75% improvement (from the baseline PASI) in IMO-8400 arm (20%) as compared to the placebo arm (none).
In Oct 2013, Idera had expanded the study to evaluate the 0.6 mg/kg once weekly dose of IMO-8400 in 12 patients. Results from the expanded study should be out by the end of the second quarter of 2014.
Idera is also developing IMO-8400 for genetically defined forms of B-cell lymphoma including Waldenström’s macroglobulinemia and diffuse large B-cell lymphoma and orphan autoimmune diseases including polymyositis and dermatomyositis. Over the rest of 2014, the company plans to enroll patients for studies evaluating IMO-8400 for Waldenström’s macroglobulinemia, diffuse large B-cell lymphoma, polymyositis and dermatomyositis.
Our Take
Positive top-line data on IMO-8400 is encouraging. The data supports the development of IMO-8400 further. Idera has another candidate, IMO-9200 (an antagonist of TLRs 7, 8, and 9), targeting certain autoimmune diseases. IMO-9200 possesses a similar mechanism of action as IMO-8400.
The company plans to submit an investigational new drug application for IMO-9200 in the second half of 2014. The encouraging data on IMO-8400 also validates IMO-9200’s mechanism of action to some extent.
Idera carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biotech sector may consider companies like Alkermes (ALKS), Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences Inc. (GILD), all of which carry a Zacks Rank #1 (Strong Buy).
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