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Omeros Announces Publication Highlighting Survival Benefits in TA-TMA Patients Treated with Narsoplimab Versus a Well-Matched External Control Group

OMER
  • Omeros Corporation announced publication of a peer-reviewed manuscript in Blood Advances regarding survival outcomes for adult patients with life-threatening TA-TMA treated with narsoplimab.
  • The study analyzed data from the pivotal clinical trial & the global expanded access program, showing significant multifold reductions in mortality risk compared to an external control group.
  • No safety signals of concern were observed in the narsoplimab-treated cohorts during the study.
  • Narsoplimab is an investigational monoclonal antibody that inhibits MASP-2, the effector enzyme of the lectin pathway of complement.
  • Unlike other complement inhibitors, narsoplimab preserves the lytic function of the classical pathway to maintain immune defense against infection.
  • A biologics license application (BLA) for narsoplimab is under review by the U.S. FDA, while a marketing authorisation application (MAA) is under review by the European Medicines Agency.
  • The FDA has granted breakthrough therapy & orphan drug designations for narsoplimab for TA-TMA, while the EMA has granted orphan drug designation for hematopoietic stem-cell transplant.
  • TA-TMA is a severe, often fatal complication of hematopoietic stem cell transplantation with a high mortality rate exceeding 90 percent in severe cases.
  • There is currently no approved therapy or established standard of care for TA-TMA.
  • Omeros is a clinical-stage biopharmaceutical company focusing on complement-mediated diseases, cancers, & addictive disorders.
  • Omeros' lead MASP-2 inhibitor narsoplimab is the primary candidate under regulatory review for TA-TMA treatment.
  • OMS1029, a long-acting MASP-2 inhibitor, completed Phase 1 clinical trials.
  • Zaltenibart (OMS906), an MASP-3 inhibitor, is in clinical development for PNH & C3 glomerulopathy.
  • Novo Nordisk has acquired global rights to zaltenibart, including associated intellectual property & assets.
  • Omeros is developing OMS527, a phosphodiesterase 7 inhibitor for cocaine use disorder, fully funded by the National Institute on Drug Abuse.
  • Omeros maintains a growing portfolio of novel molecular & cellular therapeutic programs for oncology.