The FDA has lifted a clinical hold on Intellia Therapeutics’ phase 3 Magnitude trial of nexiguran ziclumeran, or nex-z.
The trial was paused Oct. 29 after a patient developed grade 4 liver transaminase elevations and elevated bilirubin following a Sept. 30 dose of nex-z, according to a March 2 news release. The participant was hospitalized and later died.
In response, the company implemented mitigation measures agreed upon with the FDA, including enhanced monitoring of liver laboratory values, updated guidance on steroid use and stricter exclusion criteria for patients with recent cardiovascular instability or low ejection fraction. Similar protocol changes apply to Magnitude-2, which was also placed on a temporary hold.
Magnitude is a randomized, double-blind, placebo-controlled trial enrolling about 1,200 patients with transthyretin amyloidosis with cardiomyopathy. Magnitude-2 is enrolling approximately 60 patients with polyneuropathy. Both studies are evaluating a single 55-mg infusion of nex-z.
Intellia said enrollment will resume after the updated protocols are implemented.
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