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Bayer Announces Phase III REVEAL Study with Investigational PET Radiotracer Iodine 124 Evuzamitide Presented as Late-Breaker at ESC 2026

Bayer

Phase III results in patients with suspected cardiac amyloidosis were presented at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in The Journal of the American Medical Association

Not intended for UK Media

WHIPPANY, N.J., August 30, 2026--Bayer today announced the presentation of first detailed results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women's Hospital, that evaluated the investigational positron emission tomography (PET) radiotracer iodine 124 evuzamitide (I 124 evuzamitide) for the diagnosis of cardiac amyloidosis.1 The pivotal study met its primary endpoints in the assessment of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation.1 Safety data and data from secondary endpoints assessing the sensitivity and specificity in light-chain amyloidosis (AL) and, separately, in transthyretin amyloidosis (ATTR) were also presented.1 I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.

These results were shared in a late-breaking oral presentation at the European Society of Cardiology Congress 2026 (ESC) in Munich, Germany, on August 30, 2026, and simultaneously published in The Journal of the American Medical Association.

Why These Data Matter

"For people with cardiac amyloidosis, obtaining an accurate diagnosis can be challenging," said REVEAL principal investigator Dr. Sharmila Dorbala, Director of Nuclear Cardiology, Brigham and Women's Hospital, Director of Amyloidosis Research, Mass General Brigham Heart & Vascular Institute. "These challenges can lead to delays, underdiagnosis or misdiagnosis in the course of the disease."

"Bayer is proud to present this new research on cardiac amyloidosis at ESC," said Dr. Erin Bowman, Senior Medical Director of Molecular Imaging and Theranostics at Bayer. "The presentation of this data reflects our ongoing commitment to advancing research for patients affected by this disease."

Key Highlights of the Phase III REVEAL Study Results and Design
REVEAL was a multicenter, open-label, single-arm Phase III study conducted at 18 centers in the United States, evaluating 170 adults with suspected cardiac amyloidosis.

  • The Phase III REVEAL study met its primary endpoints in the assessment of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation from three independent readers.

    • Sensitivity

      • Reader 1: 94% (95% confidence interval [CI]: 85% to 98%)

      • Reader 2: 94% (95% confidence interval [CI]: 85% to 98%)

      • Reader 3: 90% (95% confidence interval [CI]: 81% to 95%)

    • Specificity

      • Reader 1: 84% (95% confidence interval [CI]: 75% to 91%)

      • Reader 2: 85% (95% confidence interval [CI]: 76% to 92%)

      • Reader 3: 89% (95% confidence interval [CI]: 81% to 95%)

  • Based on the majority read (agreement between at least two out of three readers) sensitivity was 94% (95% confidence interval [CI], 85 to 98) and specificity was 86% (95% CI, 77 to 92).

  • Data from secondary efficacy endpoints, which assessed diagnostic performance in light-chain amyloidosis (AL) as well as in transthyretin amyloidosis (ATTR) based on visual scan interpretation were also presented.

    • For the ATTR type, sensitivity from the majority read was 96% (95% CI, 87 to 100) and specificity was 86% (95% CI, 77 to 92).

    • For the AL type, sensitivity from the majority read was 95% (95% CI, 76 to 100) and specificity was 86% (95% CI, 77 to 92).

  • Among the 170 patients who received I 124 evuzamitide, 55 (32.4%) experienced at least one treatment-emergent adverse event (TEAE) from Day 1 to Day 30. Of these, 11 (6.5%) patients experienced a serious TEAE unrelated to I 124 evuzamitide; only one TEAE (fatigue) was considered related to I 124 evuzamitide.

  • The most common TEAEs, occurring in >1% of participants, were upper respiratory tract infection (2.9%), dizziness (2.4%), nausea (1.8%), vomiting (1.8%), syncope (1.8%), hyperglycemia (1.8%) and skin laceration (1.8%).

    • There were no deaths or evuzamitide related TEAEs leading to discontinuation during the study period.

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