Addressing analysts in August, Intellia Therapeutics (NASDAQ: NTLA) president and CEO John Leonard, MD, announced that, given greater-than-expected patient enrollment in a Phase III trial assessing nexiguran ziclumeran (nex-z) in transthyretin amyloidosis with cardiomyopathy (ATTR-CM), the company would increase enrollment to approximately 1,200 patients.
“We expect that we will enroll more patients this year in our cardiomyopathy program than originally planned,” Leonard predicted.
Those lofty expectations crashed to earth starting October 27 when Intellia voluntarily paused dosing and screening in the 650+-patient global trial, called MAGNITUDE (NCT06128629), and a second 47-patient Phase III study of nex-z called MAGNITUDE-2 (NCT06672237).
The pauses followed hospitalization of a MAGNITUDE patient who experienced Grade 4 liver transaminases and increased total bilirubin after being dosed with nex-z.
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