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Omeros Says FDA Grants Orphan Drug Designation To MASP-3 Inhibitor OMS906

Omeros Corp (OMER) announced Friday that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

OMS906 targets mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the alternative pathway of the complement system. MASP-3 converts pro-complement factor D (pro-CFD) to mature CFD.

PNH is a rare, life-threatening disease characterized by red blood cell destruction, blood clots and impaired bone marrow function.

Based on its mechanism of action as well as the pharmacokinetic/pharmacodynamic (PK/PD) profile shown in a completed Phase 1 study, OMS906 has the potential to offer a favorable safety profile and more convenient dosing than other drugs on the market or in development for PNH.

Omeros recently completed a Phase 1 trial of OMS906 in healthy subjects and expects to begin enrollment this summer in a clinical trial assessing OMS906 in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab.

The company is also targeting efficacy data in populations of treatment-naïve PNH and C3 glomerulopathy patients by early 2023. Based on the results of the completed Phase 1 trial, administration of OMS906 is expected to be once monthly to once quarterly intravenously or subcutaneously.

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