Omeros Corporation reported on March 21, 2025, that clinical trial site activation is underway for its Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key activator of the alternative pathway of complement.
A total of 120 clinical investigative sites across 30 countries have been selected for participation in the zaltenibart Phase 3 program. Data needed for submission of the biologics licensing application (BLA) and global approval dossiers for zaltenibart in PNH remain on track for the fourth quarter of 2026.
The Phase 3 clinical trials will evaluate intravenous zaltenibart dosed once every eight weeks, offering a potentially convenient dosing schedule. Both the FDA and European regulators have agreed with the trial designs, which include head-to-head comparisons against C5 inhibitors, and all required drug product has been manufactured.
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