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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: 22 Aug 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

    • 08 Aug 2024 According to a Passage Bio media release, the company plans to present updated interim safety and biomarker data from Cohort 1 FTD-GRN patients treated with PBFT02 at 14th International Conference on Frontotemporal Dementias (ISFTD2024) on Friday, 20 September 2024 in an oral presentation by Juan Chavez, M.D., vice president of clinical development at Passage Bio.
    • 08 Aug 2024 According to a Passage Bio media release, first FTD-GRN patient is enrolled in Cohort 2 of this trial, following IDMC review of all available Cohort 1 safety data. Recruitment for subsequent Cohort 2 patients is ongoing across 7 clinical trial sites in Brazil, Canada, the United States and Europe.
    • 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.

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