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A Phase 1/2 Open-Label, Ascending Dose, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of AVB-101 Administered by Bilateral Intrathalamic Infusion in Subjects With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)

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Trial Profile

A Phase 1/2 Open-Label, Ascending Dose, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of AVB-101 Administered by Bilateral Intrathalamic Infusion in Subjects With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 May 2025

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At a glance

  • Drugs AVB 101 (Primary)
  • Indications Frontotemporal dementia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms ASPIRE-FTD; FTD-GRN
  • Sponsors AviadoBio

Most Recent Events

  • 15 May 2025 According to an AviadoBios media release, patient enrollment is now open in the UK's Cambridge University Hospitals NHS Foundation Trust (CUH) and University College London (UCL) is also expected to open for patient recruitment shortly.
  • 01 May 2025 According to an AviadoBios media release, the company intends to initiate dosing for a third cohort in Q3 2025 and biomarker data readout is expected in 2026. Additional countries are expected to join the trial in the near future.
  • 01 May 2025 According to an AviadoBios media release, the second dose cohort in this study is completed and 6th patient has been dosed. The company announced this milestone at the Association for Frontotemporal Degeneration (AFTD) annual caregiver conference in Denver.

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