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A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the Cisterna Magna of Adult Subjects With Frontotemporal Dementia and Mutations in the Progranulin Gene

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A Phase 1b Open-Label, Multicenter, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of a Single Dose of PBFT02 Delivered Into the Cisterna Magna of Adult Subjects With Frontotemporal Dementia and Mutations in the Progranulin Gene

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs PBFT 02 (Primary)
  • Indications Frontotemporal dementia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacogenomic; Therapeutic Use
  • Acronyms upliFT-D
  • Sponsors Passage Bio

    • Most Recent Events

    • 16 Jul 2024 According to a Passage Bio media release, the company received positive feedback in its Type C meeting process with the U.S. FDA on its proposal to evaluate PBFT02 for treating frontotemporal dementia patients with mutations in the C9orf72 gene. The company intends to amend protocol of this study to include FTD-C9orf72 patients. The company plans to submit the revised trial protocol to health authorities and ethics committees promptly and expects to initiate dosing in 1H 2025.
    • 14 May 2024 According to a Passage Bio media release, the company completed dosing of Cohort 1, with five patients now having received Dose1 of PBFT02
    • 04 Mar 2024 According to a Passage Bio media release, in the first half of 2024, the company expects to complete dosing for Cohort 1 patients; Following the positive data, multiple GRN+ patients have been identified and are being evaluated for eligibility across seven clinical trial sites in Brazil, Canada, the United States and Europe.
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