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A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the ATXN2 Gene

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Trial Profile

A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the ATXN2 Gene

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs ION 541 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; First in man
  • Acronyms ALSpire
  • Sponsors Biogen

Most Recent Events

  • 16 May 2024 According to an Ionis Pharmaceuticals media release, company announced the decision to terminate development of BIIB105 (ION541) for amyotrophic lateral sclerosis (ALS) based on topline results from the Phase 1/2 ALSpire study.
  • 16 May 2024 Status changed from active, no longer recruiting to discontinued, according to Ionis Pharmaceuticals Inc. media release.
  • 16 May 2024 According to Ionis Pharmaceuticals Inc. media release, data from this study will be presented at the upcoming European Network to Cure ALS (ENCALS) meeting in Stockholm, Sweden in June.

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