Regeneron Pharmaceuticals ((REGN)), Intellia Therapeutics Inc ((NTLA)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals and Intellia Therapeutics are conducting a Phase 3 clinical study titled ‘MAGNITUDE-2’ to evaluate the efficacy and safety of NTLA-2001 in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This study aims to assess the impact of a single dose of NTLA-2001 compared to a placebo, highlighting its potential significance in treating this rare genetic disorder.
The intervention being tested is a biological treatment named nexiguran ziclumeran (NTLA-2001), administered as a single 55 mg intravenous infusion. The purpose of this treatment is to provide a novel therapeutic option for individuals suffering from ATTRv-PN.
The study is designed as a multinational, randomized, double-blind, placebo-controlled trial involving approximately 50 participants. Participants are randomly assigned to receive either NTLA-2001 or a placebo, with the option to switch treatments at Month 12 or 18. The study employs a quadruple masking approach to ensure unbiased results.
The study began on November 22, 2024, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on July 28, 2025, indicating ongoing progress in the trial.
This clinical update could influence the stock performance of both Regeneron and Intellia, as successful results may enhance investor confidence and position the companies favorably against competitors in the gene-editing and pharmaceutical sectors.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.