Omeros Files CTA for aHUS Candidate


Omeros Corporation (OMER) recently filed a Clinical Trial Application (:CTA) with the European regulatory authorities to initiate studies on OMS721. OMS721 is Omeros’ lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) program.

OMS721 will be primarily developed for the treatment of atypical hemolytic uremic syndrome (aHUS), which is a rare but life-threatening form of thrombotic microangiopathy (TMA). Omeros plans to initiate a phase I study at the beginning of the next quarter subject to a positive regulatory review of its CTA.

Omeros’ placebo-controlled, double-blind, single-ascending-dose phase I study on OMS721 will be evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of the candidate administered subcutaneously in healthy subjects.

Omeros intends to advance OMS721 in phase II development in aHUS patients as soon as it completes the phase I study.

We remind investors that currently the only approved drug for the treatment of aHUS is Alexion Pharmaceuticals’ (ALXN) Soliris. Soliris is also approved for the treatment of paroxysmal nocturnal hemoglobinuria (:PNH). Soliris sales came in at $1.13 billion in 2012.

Meanwhile, Omeros was recently in the news for its Huntington's disease candidate OMS824, which is the company’s lead compound in its phosphodiesterase 10 (PDE10) program. Last week the US Food and Drug Administration cleared the Investigational New Drug Application of OMS824 for treating patients suffering from Huntington's disease. Omeros plans to advance OMS824 in a phase II development for the treatment of Huntington's disease in the third quarter of 2013.

Omeros, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Other biopharma stocks such as Jazz Pharmaceuticals (JAZZ) and Santarus Inc. (SNTS) currently look more attractive. Both stocks carry a Zacks Rank #1 (Strong Buy).

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