Bayer's Phase III REVEAL Study Meets Primary Endpoints for Cardiac Amyloidosis Diagnosis

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โดย Business Wire·US·Read original
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Bayer announced that the Phase III REVEAL study, evaluating the investigational PET radiotracer iodine 124 evuzamitide for diagnosing cardiac amyloidosis, met its primary endpoints in sensitivity and specificity, with results presented as a late-breaker at ESC 2026 and published in JAMA. The study, conducted at 18 U.S. centers with 170 adults, showed a majority-read sensitivity of 94% and specificity of 86% for cardiac amyloidosis, with subtype analyses for ATTR and AL also meeting secondary endpoints. Safety data indicated that 32.4% of patients experienced at least one treatment-emergent adverse event, with only one related to the radiotracer, and no deaths or related discontinuations. I 124 evuzamitide, previously granted Breakthrough Therapy Designation and Orphan Drug status, is not yet approved, and Bayer plans to discuss regulatory submission with the FDA and other authorities.

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Phase III REVEAL study met primary endpoints for cardiac amyloidosis diagnosis, supporting regulatory submission.

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