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A Phase II open-label pilot study to evaluate the safety and efficacy of subcutaneously administered ELX-02 in patients with Alport syndrome with Col4A5 and Col4A3/4 nonsense mutation

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Trial Profile

A Phase II open-label pilot study to evaluate the safety and efficacy of subcutaneously administered ELX-02 in patients with Alport syndrome with Col4A5 and Col4A3/4 nonsense mutation

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs Exaluren (Primary)
  • Indications Hereditary nephritis
  • Focus Adverse reactions; Proof of concept
  • Sponsors Eloxx Pharmaceuticals; TMC Pharma

Most Recent Events

  • 12 Nov 2024 According to Eloxx Pharmaceuticals media release, in late October 2024, Daniel Gale, Professor of Nephrology at University College London Department of Renal Medicine, presented new results from this study in a late-breaking presentation at American Society of Nephrology (ASN) Kidney Week. Results justify conducting a larger clinical trial of ELX-02 in NMAS to confirm the clinical benefit.
  • 16 Apr 2024 According to Eloxx Pharmaceuticals media release, the company presented updated results from this study in 3 NMAS patients treated with ELX-02 at Alport Workshop Meeting in March.
  • 16 Apr 2024 According to Eloxx Pharmaceuticals media release, in April, the FDA Office of Orphan Products Development (OOPD) granted ODD for ELX-02 for the treatment of Alport Syndrome. The designation was based on a review of the prevalence of NMAS and the data from this Proof-of-concept Phase 2 Study.

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