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A Phase 1/2 Randomized, Blinded, Dose-escalation Study to Evaluate the Safety and Efficacy of Intrathecal Administration of AAV9-ABCD1 Gene Therapy (SBT101) in Adult Patients With Adrenomyeloneuropathy

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Trial Profile

A Phase 1/2 Randomized, Blinded, Dose-escalation Study to Evaluate the Safety and Efficacy of Intrathecal Administration of AAV9-ABCD1 Gene Therapy (SBT101) in Adult Patients With Adrenomyeloneuropathy

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Oct 2023

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At a glance

  • Drugs SBT 101 (Primary)
  • Indications Adrenomyeloneuropathy
  • Focus Adverse reactions; First in man
  • Acronyms PROPEL
  • Most Recent Events

    • 04 Oct 2023 According to a SwanBio Therapeutics media release, trial is currently active in the United States and is expanding into Europe following the recent approval of its Clinical Trial Application (CTA) from the Central Committee on Research Involving Human Subjects (CCMO) in the Netherlands.
    • 04 Oct 2023 According to a SwanBio Therapeutics media release, Syncona Investment Management Limited, has made an additional $10 million commitment to fund the second cohort of this trial.
    • 04 Oct 2023 According to a SwanBio Therapeutics media release, patients in the first cohort received a single intrathecal administration of the lower of two planned doses and were assessed for treatment safety and tolerability. Dosing procedures were completed successfully. No serious adverse events related to the procedure, nor the gene therapy product, have been reported to date.
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