Omeros Corp. (OMER), Friday announced that it has initiated clinical trial site activation for its Phase 3 program evaluating zaltenibart or OMS906 in paroxysmal nocturnal hemoglobinuria or PNH.
The company remains on track to complete the trials and submit a Biologics License Application or BLA in the fourth quarter 2026.
PNH is a rare, life-threatening blood disorder characterized by the destruction of red blood cells, leading to anemia, fatigue, and increased risk of blood clots.
The disease is currently treated with C5 inhibitors, but these fail to address extravascular hemolysis, a key issue in PNH management.
Zaltenibart is an investigational MASP-3 inhibitor, designed to target both intravascular and extravascular hemolysis, offering potential advantages over existing therapies.
Unlike other complement inhibitors that require frequent dosing, zaltenibart is administered once every eight weeks via intravenous infusion.
The Phase 3 program includes two parallel trials:
-- One in treatment-naïve PNH patients not receiving complement inhibitors.
Another in patients with an inadequate response to C5 inhibitors, such as ravulizumab or eculizumab.
-- A total of 120 clinical sites across 30 countries have been selected for participation, with patient recruitment already underway.
Phase 2 data, previously presented at the American Society of Hematology and European Hematology Association Annual Meetings, demonstrated that zaltenibart effectively:
-- Inhibits both intravascular and extravascular hemolysis.
-- Achieves gender-normal hemoglobin levels in both men and women.
-- Has shown no safety signals of concern.
Omeros is also preparing for the potential commercialization of zaltenibart.
The company has incorporated patient-reported outcome or PRO measures in the Phase 3 design, following recommendations from the German Federal Joint Committee, to support market access and pricing negotiations.
"The zaltenibart Phase 2 data have demonstrated important differentiators from currently marketed agents, and we expect those same advantages to be evidenced in the Phase 3 trials," said Gregory A. Demopulos, M.D., Omeros' Chairman and CEO.
He further added, "We look forward to our Phase 3 readout late next year and to bringing a better treatment option to PNH patients and their physicians."
The global PNH market was valued at $3.8 billion in 2023 and is projected to exceed $11.7 billion by 2034. Beyond PNH, zaltenibart is also being evaluated in a Phase 2 clinical trial for C3 glomerulopathy, with additional indications under consideration.
Currently, OMER is trading at $9.29, up by 2.09 percent on the Nasdaq.
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