FDA lifts clinical hold on MAGNITUDE-2 trial of nex-z in ATTRv polyneuropathy

Intellia Therapeutics/Nex-z (NTLA-2001)

The FDA removed the clinical hold on MAGNITUDE-2, the Phase 3 trial of nex-z for hereditary ATTR amyloidosis with polyneuropathy. Intellia agreed to enhanced liver-safety monitoring, including closer tracking of liver laboratory tests, following Grade 4 liver transaminase elevations observed in an earlier trial patient.

• The hold on MAGNITUDE-2 was lifted after the company and FDA agreed on enhanced safety monitoring of liver function.
• MAGNITUDE, the cardiomyopathy trial, remains under clinical hold.
• nex-z (nexiguran ziclumeran) is an in vivo CRISPR therapy targeting transthyretin amyloidosis.