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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2024

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At a glance

  • Drugs Sodium phenylbutyrate/ursodoxicoltaurine (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PHOENIX
  • Sponsors Amylyx Pharmaceuticals

    • Most Recent Events

    • 14 Aug 2024 Planned End Date changed from 1 Mar 2024 to 1 Jan 2026.
    • 08 Aug 2024 According to an Amylyx Pharmaceuticals media release, The decrease in payroll and personnel-related costs was primarily related to a decrease in the number of employees as a result of the restructuring plan announced on April 4, 2024. The decrease in consulting and professional services is primarily due to a decrease in commercial sales and marketing activity as a result of removing RELYVRIO/ALBRIOZA from the market in the U.S. and Canada based on topline results from the Phase 3 PHOENIX trial.
    • 08 Aug 2024 According to an Amylyx Pharmaceuticals media release, the decrease in payroll and personnel-related costs was primarily related to a decrease in the number of employees as a result of the restructuring plan announced on April 4, 2024. The decrease in clinical expenses is primarily due to a decrease in spending on AMX0035 for the treatment of ALS due to the completion of the Phase 3 PHOENIX trial.

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