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Trials & Filings

Omeros TMA Treatment Passes Ph I

Well tolerated with no AEs observed

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Omeros Corp. posted positive data in a Phase I trial of OMS721, the company’s lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). Subcutaneous administration of OMS721 achieved a high degree of lectin pathway inhibition. The drug was well tolerated and no drug-related adverse events were observed.

A Phase II clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), a family of disorders that occurs in the microcirculation of the body’s organs, most commonly the kidney and brain, is expected to begin enrollment in early 2014.

The Phase I trial was a placebo-controlled, double-blind, single-ascending-dose study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered either intravenously or subcutaneously in healthy subjects. To date, four cohorts of subjects have received OMS721 or placebo by subcutaneous injection at increasing dose levels. OMS721 or placebo injections were well tolerated in all subjects. No clinically significant abnormalities on laboratory tests or electrocardiograms have been observed. At the highest subcutaneous dose administered to date, OMS721 achieved serum concentrations that resulted in a high degree of inhibition of lectin pathway activation. The serum concentrations seen in the Phase I subjects are similar to those associated with efficacy in animal models of diseases linked to the lectin pathway, including those of TMA and neovascular age-related macular degeneration (AMD), a leading cause of vision loss in individuals over 60 years of age.

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