Intellia discloses grade 4 liver transaminase elevation in MAGNITUDE trial

In a regulatory filing, Intellia Therapeutics (NTLA) said: “Enrollment in our global Phase 3 HAELO study of NTLA-2002 for hereditary angioedema is on track. We expect to complete enrollment in the third quarter of 2025 and submit a biologics license application in the second half of 2026 to support plans for a potential U.S. commercial launch in 2027. Enrollment in our global Phase 3 MAGNITUDE-2 study of nex-z for ATTRv-PN is also progressing well. The MAGNITUDE-2 study is designed to measure clinical outcomes and evaluate how a single dose of nex-z can lead to reduction in serum TTR. We expect to complete MAGNITUDE-2 to support a potential BLA submission by 2028 and potential U.S. commercial launch in 2029. In addition, enrollment in our global Phase 3 MAGNITUDE study of nex-z for ATTR-CM is progressing according to our expectations. Currently, we have enrolled approximately 365 patients in the MAGNITUDE study, out of an expected total enrollment of approximately 765 patients, and anticipate enrollment completion by early 2027. Over two hundred patients have been dosed with nex-z in the MAGNITUDE study. To date, reported adverse events have been similar in nature to the reported adverse events in the Phase 1 study of nex-z for ATTR amyloidosis, and have included infusion-related reactions and asymptomatic liver transaminase elevations. There has been a single, recent, asymptomatic patient with grade 4 liver transaminase elevations based on laboratory tests, which appear to be resolving without hospitalization or medical intervention and have fallen to grade 3 ALT and grade 2 AST elevations. We continue to monitor these events as the MAGNITUDE study progresses.” Shares of Intellia Therapeutics are down 13% in premarket trading.