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HALOS: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION582 in Patients With Angelman Syndrome

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Trial Profile

HALOS: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION582 in Patients With Angelman Syndrome

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 16 Nov 2025

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At a glance

  • Drugs ION 582 (Primary)
  • Indications Angelman syndrome
  • Focus Adverse reactions; First in man
  • Acronyms HALOS
  • Sponsors Ionis Pharmaceuticals

Most Recent Events

  • 07 Oct 2025 According to an Ionis Pharmaceuticals Media Release, company has plans to share new, positive 18-month long-term extension data from the phase 2 HALOS study of ION582 for Angelman syndrome, a severe neurodevelopmental disorder with no approved disease-modifying treatments.
  • 11 Sep 2025 Number of treatment arms increased from 9 to 10 by the addition of Experimental: Part 1 MAD: Cohort F arm. Planned enrollment increased. Minimum inclusion age reduced from 2 years to 0 years, since a cohort of patients with Angelman Syndrome under the age of 2 years old will also be included.
  • 11 Sep 2025 Planned number of patients changed from 55 to 70.

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