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Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE Phase 3 Clinical Trial in ATTR-CM

NTLA
  • The FDA has removed the clinical hold on the Investigational New Drug application for Intellia Therapeutics' MAGNITUDE Phase 3 trial of nexiguran ziclumeran (nex-z) for transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
  • The clinical hold was originally imposed on October 29, 2025, following Grade 4 liver transaminases & increased total bilirubin in a MAGNITUDE patient.
  • Intellia & the FDA have aligned on mitigation measures including enhanced liver monitoring, short-term steroid treatment guidance for elevated transaminases, & exclusion of patients with specific liver abnormalities.
  • Additional exclusion criteria for MAGNITUDE now include patients with recent cardiovascular instability or an ejection fraction below 25% at screening.
  • Enrollment activities for both MAGNITUDE (ATTR-CM) & MAGNITUDE-2 (hereditary ATTR with polyneuropathy) are resuming following the resolution of the January hold on the latter trial.
  • MAGNITUDE is a randomized, double-blind, placebo-controlled trial evaluating a single 55 mg infusion of nex-z in approximately 1,200 ATTR-CM patients.
  • MAGNITUDE-2 is a randomized, double-blind, placebo-controlled trial evaluating a single 55 mg infusion of nex-z in approximately 60 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN).
  • Nex-z utilizes CRISPR/Cas9 technology to inactivate the TTR gene & has received Orphan Drug & RMAT designations from the FDA.
  • Intellia is developing nex-z in collaboration with Regeneron Pharmaceuticals, Inc.