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Phase 1/2 Investigation of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (Pioneer-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002

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Trial Profile

Phase 1/2 Investigation of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (Pioneer-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 May 2026

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At a glance

  • Drugs Methylprednisolone (Primary) ; Prednisone (Primary) ; VTx-002-VectorY-Therapeutics (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; First in man
  • Acronyms ALS; PIONEER-ALS
  • Sponsors VectorY

Most Recent Events

  • 28 Apr 2026 According to VectorY Therapeutics media release, approval covers clinical trial sites in Belgium and The Netherlands. The company recently announced that it has treated its first participant at its lead clinical trial site in the United States.
  • 28 Apr 2026 According to VectorY Therapeutics media release, company announced the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and, the European Medicines Agency (EMA) have both granted the company clearance to initiate a first-in-human clinical trial of its investigational first-in-class vectorized antibody targeting TDP-43 pathology in people living with amyotrophic lateral sclerosis (ALS).
  • 09 Feb 2026 According to VectorY Therapeutics media release, first patient has been dosed in this study at the lead clinical trial site, the Sean M. Healey & AMG Center for ALS at Mass General Brigham.

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