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A Phase 1/2, Open-Label, Ascending-Dose Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT845, an AAV8-Delivered Gene Transfer Therapy in Patients With Late Onset Pompe Disease

Trial Profile

A Phase 1/2, Open-Label, Ascending-Dose Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT845, an AAV8-Delivered Gene Transfer Therapy in Patients With Late Onset Pompe Disease

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Nov 2019

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At a glance

  • Drugs AT 845 (Primary)
  • Indications Glycogen storage disease type II
  • Focus Adverse reactions; Pharmacodynamics; Proof of concept
  • Acronyms FORTIS
  • Sponsors Audentes Therapeutics
  • Most Recent Events

    • 21 Nov 2019 Status changed from planning to not yet recruiting.
    • 07 Nov 2019 According to an Audentes Therapeutics media release, the IND application is under review with the U.S. Food & Drug Administration (FDA). The clinical start-up activities are underway. The company is planning on for initiating a screening study with US trial sites to accelerate patient identification for enrollment into this study.
    • 07 Jan 2019 According to an Audentes Therapeutics media release, company is planning to file IND in the third quarter of 2019.
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