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Intellia Therapeutics Patient Death Prompts FDA Clinical Hold on CRISPR Heart Disease Trials
The FDA halted Intellia's phase 3 CRISPR trials after liver toxicity caused one death, with less than 1% of patients affected in the MAGNITUDE trial, company said.
- On September 30, Intellia Therapeutics acknowledged an elderly MAGNITUDE trial participant died after dosing with nexiguran ziclumeran , and shortly after, the U.S. Food and Drug Administration imposed a clinical hold on both MAGNITUDE trials.
- Laboratory reports showed AST and ALT levels above three times the upper limit and total bilirubin over two times the upper limit, meeting Hy's Law criteria for serious liver injury.
- Enrollment data show MAGNITUDE trial included more than 650 patients and MAGNITUDE-2 trial had 47, with grade 4 transaminase elevations in less than 1%; Intellia ordered stepped-up monitoring and paused dosing after learning of hospitalization 24 days post-dosing.
- Shares plunged nearly 62% after Intellia suspended guidance on clinical timelines and will update investors following FDA alignment on next steps.
- Analysts say the event complicates the TTR program's path but resuming dosing could be possible after identifying causes and agreeing protocol changes with the FDA.
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Anti-Aging, Acupuncture and Health NewsTrial Patient Dies After Receiving CRISPR Gene Therapy
(MedPage Today) -- A patient with transthyretin amyloidosis (ATTR) who received the investigational gene therapy nexiguran ziclumeran (nex-z) in a phase III trial died, Intellia Therapeutics said. The news came days after the company paused the...
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Leaning Left1Leaning Right2Center4Last UpdatedBias Distribution57% Center
Bias Distribution
- 57% of the sources are Center
57% Center
14%
C 57%
R 29%
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