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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS

Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs CNM Au8 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms RESCUE-ALS
  • Sponsors Clene Nanomedicine

Most Recent Events

  • 13 Nov 2024 According to a Clene media release, On November 1, 2024, the Company met with the FDA in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS for CNM-Au8, including biomarker and related clinical and survival data, and are currently awaiting meeting minutes from this meeting.
  • 16 Sep 2024 According to a Clene media release, company announced that it will meet in-person with the U.S. Food and Drug Administration (FDA) before the end of November 2024 to discuss CNM-Au8 development for ALS.
  • 21 Dec 2023 Results of post hoc analysis presented in the Clene Nanomedicine Media Release.

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