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A Phase 2, Uncontrolled, Three-Stage, Dose-Escalation Cohort Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Clinical Activity of OMS721 in Adults With Thrombotic Microangiopathies

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Trial Profile

A Phase 2, Uncontrolled, Three-Stage, Dose-Escalation Cohort Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Clinical Activity of OMS721 in Adults With Thrombotic Microangiopathies

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Jan 2025

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At a glance

  • Drugs Narsoplimab (Primary)
  • Indications Atypical Haemolytic Uraemic Syndrome; Thrombotic microangiopathy; Thrombotic thrombocytopenic purpura
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Omeros Corporation
  • Most Recent Events

    • 16 Jan 2025 Results related to the primary endpoint analysis for narsoplimab presented in the Omeros Corporation media release.
    • 19 Dec 2024 According to an Omeros Corporation media release, based on the results of primary statistical analysis company will resubmit to FDA as soon as possible its narsoplimab Biologics License Application (BLA) for TA-TMA followed by our planned submission of the corresponding European marketing authorisation application in the second quarter of 2025.
    • 19 Dec 2024 Results of primary statistical analysis (agreed with the FDA for narsoplimab) presented in the Omeros Corporation Media Release.

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