Omeros Corp. (OMER) has reported positive data from a phase I study on OMS721 following the completion of dosing. OMS721 is being evaluated for the prevention of complement-mediated thrombotic microangiopathies (TMAs).
This ongoing placebo-controlled, double-blind, single-ascending-dose phase I study is evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 in healthy subjects.
Seven cohorts of subjects were administered either OMS721 or placebo at increasing dosage strengths. The data showed that both the subcutaneous and intravenous administration of OMS721 achieved a high degree of lectin pathway inhibition, when evaluated at the highest dose. The data also showed that the drug was well tolerated with no adverse events being observed.
In Nov 2013, Omeros had announced positive interim data from this study, based on evaluation of four cohorts of subjects receiving OMS721. The data showed that a subcutaneous administration of OMS721 achieved a high degree of lectin pathway inhibition.
Omeros plans to commence a phase II study in the first quarter of 2014 to evaluate OMS721 for the prevention of complement-mediated TMAs.
We note that OMS721 enjoys orphan drug status in the U.S. for the prevention of complement-mediated TMAs. Omeros has global rights to MASP-2 and all therapeutics targeting MASP-2. On the back of encouraging data from the phase I study, the selection of the dose levels for the phase II study of OMS721 will be ascertained.
Omeros' most advanced candidate, Omidria, is filed for approval in the U.S. and EU for the treatment of patients undergoing intraocular lens replacement surgery. Omeros expects to market Omidria in the second half 2014.
Omeros carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Lannett Company, Inc. (LCI), Endocyte Inc. (ECYT) and Actelion Ltd. (ALIOF), all of which carry a Zacks Rank #1 (Strong Buy).
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