Business
Omeros Corporation Provides Update of Ongoing Zaltenibart Phase 3 PNH Clinical Trial Program
SEATTLE, March 21, 2025--Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of the alternative pathway of complement. Zaltenibart inhibits the intravascular hemolysis treated by C5 inhibitors as well as the extravascular hemolysis
About this update from Omeros Corporation
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":342,"url":"https://media.zenfs.com/en/business-wire.com/451e0e1db7d2447a7e399b0f158ad03f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Vf._engkth31RLOTa2.Ytg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTY4NDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/451e0e1db7d2447a7e399b0f158ad03f","width":480,"height":342}},"lazy":false},{"type":"text","content":"-- Phase 3 Data Needed for BLA Submission Expected in the Fourth Quarter 2026 --","length":80,"tagName":"p","attribs":{}},{"type":"text","content":"SEATTLE, March 21, 2025--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of the alternative pathway of complement. Zaltenibart inhibits the intravascular hemolysis treated by C5 inhibitors as well as the extravascular hemolysis caused by C5 inhibitors in patients suffering from PNH while leaving intact the infection-fighting lytic arm of the classical pathway of complement.","length":665,"tagName":"p"},{"type":"text","content":"A total of 120 clinical investigative sites across 30 countries have been chosen for clinical trial participation in the zaltenibart Phase 3 program in PNH, a good number of which have already identified pools of PNH patients ready to participate in the zaltenibart trials, and Omeros continues collaborating with sites to identify additional eligible and already available PNH patients. 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.","length":559,"tagName":"p"},{"type":"text","content":"The Phase 3 clinical trials will evaluate intravenous zaltenibart dosed once every eight weeks. Currently marketed upstream complement inhibitors require dosing orally twice daily, orally three times daily in conjunction with C5 inhibitor treatment, or subcutaneous infusions twice weekly. Zaltenibart’s conveniently infrequent dosing together with its ability to inhibit both int...