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A pivotal Phase 2/3 study of Spinogenix in patients with the amyotrophic lateral sclerosis (ALS)

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Trial Profile

A pivotal Phase 2/3 study of Spinogenix in patients with the amyotrophic lateral sclerosis (ALS)

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 14 Jun 2021

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At a glance

  • Drugs SPG 302 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 14 Jun 2021 New trial record
    • 07 Jun 2021 According to a Spinogenix media release, the company has successful completed the pre-IND (Investigational New Drug) interaction with the FDA regarding the development plan for SPG302. The FDA agreed to the overall development program including this first-in-human Phase 1/2 clinical study followed by a Phase 2/3 Pivotal trial based on safety/PK/biomarker data.
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