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A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy Followed by an Open-Label Extension

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Trial Profile

A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy Followed by an Open-Label Extension

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Oct 2024

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At a glance

  • Drugs ALXN 2220 (Primary)
  • Indications Cardiomyopathies
  • Focus Adverse reactions; First in man
  • Sponsors Neurimmune Therapeutics

Most Recent Events

  • 14 Oct 2024 According to an AstraZeneca media release, the U.S. Food and Drug Administration (FDA) has granted Alexion, AstraZeneca Rare Disease Fast Track designation for the development of ALXN2220 (formerly NI006) for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM), based on the results of a Phase 1b trial conducted by Neurimmune and published in The New England Journal of Medicine in 2023
  • 02 Sep 2024 Results assessing the long-term safety, tolerability and efficacy of ALXN2220 treatment in Cardiomyopathies were published at the ESC Congress 2024 - Annual Congress of the European Society of Cardiology
  • 27 Aug 2024 According to an AstraZeneca media release, data from this study will be presented at at the ESC Congress 2024, a scientific congress of the European Society of Cardiology (ESC), on September 1, 17:48 UK time.

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