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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

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: 08 Mar 2024

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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

    • 13 Dec 2022 Trial design presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 08 Nov 2022 According to an Omeros Corporation media release, The decision specifically suggests that the narsoplimab BLA be resubmitted along with evidence of improved survival from patients in the pivotal trial when compared to an appropriate historical control group and a comparison of the current response data from the completed pivotal trial to a threshold derived from an independent literature analysis. It also notes out that even in the absence of the independent literature analysis, strong evidence.
    • 08 Nov 2022 According to an Omeros Corporation media release, FDA makes a decision about Omeros Corporation's formal dispute resolution request for narsoplimab. The decision suggests a course of action for the re-submission of the BLA based on survival data from the completed pivotal trial versus a historical control group. The request was denied.
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