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An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012

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Trial Profile

An Intermediate Expanded Access Protocol With CNM-Au8 for Amyotrophic Lateral Sclerosis for NIH Grant RFA-NS-23-012

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 14 May 2025

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At a glance

  • Drugs CNM Au8 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Expanded access; Therapeutic Use
  • Sponsors Clene Nanomedicine

Most Recent Events

  • 07 May 2025 According to Clene Nanomedicine media release, the company is collecting neurofilament light chain (NfL) biomarker data from this study for evaluation in the Q3 to satisfy the FDA recommendation for additional NfL data, in an upcoming meeting in the Q2 with the USFDA to reach agreement on its statistical analysis plan (SAP). This data will also support the planned submission of the ALS Accelerated Approval NDA in the Q4 of 2025.
  • 10 Dec 2024 According to a Clene Australia media release, Clene intends to follow the FDAs recommendation to provide data from the ongoing EAPs and believes that it can address the FDAs requests. This additional NfL biomarker collection and analyses to support NDA submission is planned to be completed during second quarter of 2025
  • 09 May 2024 Status changed from planning to recruiting.

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