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news.Omeros has filed an orphan drug application with the US FDA for OMS721, used to treat atypical hemolytic uremic syndrome (aHUS).
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OMS721 works by blocking the lectin pathway of the complement system while leaving intact the classical pathway and selectively inhibits MASP-2 representing the acquired immune response to infection.
Omeros chairman and chief executive officer Gregory Demopulos said OMS721 meets the criteria for orphan drug designation.
"We plan to file for the same designation in Europe, and we remain on track to begin clinical trials early this summer," Demopulos added.
"The potential indications for OMS721 span a wide range of attractive markets in both orphan and highly prevalent diseases, and we are excited to evaluate its efficacy in patients."
Designed to be self-administered by subcutaneous injection, OMS721 is convenient for patients.
As the drug targets only the lectin pathway, the drug candidate is not associated with increased infection risk.