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A phase III trial of GTX-102 for Ataxia telangiectasia

Trial Profile

A phase III trial of GTX-102 for Ataxia telangiectasia

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2023

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At a glance

  • Drugs Betamethasone (Primary)
  • Indications Ataxia telangiectasia
  • Focus Registrational; Therapeutic Use
  • Sponsors Acasti Pharma
  • Most Recent Events

    • 14 Feb 2023 According to an Acasti media release, based on data from PK bridging study, the company will work with its clinical experts and the FDA to determine the optimal final dosing regimen for GTX-102 for phase 3 design. The company lan to seek clarifying guidance from the FDA on the study design at a Type B meeting. Trial will initiate following the Type B meeting.
    • 11 Aug 2022 According to an Acasti media release, the study is expected to be initiated in the second half of calendar 2023.
    • 21 Jun 2022 According to an Acasti media release, if the study meets the primary endpoint, an NDA filing under Section 505(b)(2) would follow.
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