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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: 30 Aug 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

    • 07 Aug 2024 According to an Omeros Corporation media release, the company has submitted an analysis plan to assess existing clinical trial data along with other evidence proposed to be included in a resubmission of BLA for narsoplimab in TA-TMA. The company is engaged in ongoing discussions with the FDA regarding the analysis plan and the other evidence proposed to be included in the submission. Meeting with FDA has been scheduled.
    • 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.

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