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. -- (Business Wire)
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.
About Investigational Iodine 124 Evuzamitide
Iodine 124 evuzamitide (I 124 evuzamitide) is an investigational PET radiotracer – a radioactive diagnostic imaging agent injected into the body before a PET scan to assist with visualization – being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide, also known as AT-01, is one of two investigational amyloid radiotracers that Bayer acquired from Attralus, Inc.2
I 124 evuzamitide was previously granted Breakthrough Therapy Designation by the U.S. FDA for PET imaging in patients with suspected or known cardiac amyloidosis. It was also granted Orphan Drug status for both AL and ATTR in the U.S. and the EU.3 I 124 evuzamitide is currently under investigation and has not been approved by any regulatory authority. Bayer plans to discuss these data and submission for regulatory approval with the FDA and other health authorities.
About the REVEAL Study4
The REVEAL (“Research with EVuzamitide I 124 to Elucidate Cardiac AmyLoidosis”) study was an investigator-initiated Phase III clinical trial of the investigational diagnostic imaging agent I 124 evuzamitide in patients with suspected cardiac amyloidosis. Brigham and Women’s Hospital in Boston, MA, was the study sponsor.
The main purpose of the study was to evaluate the efficacy and safety of the investigational radiotracer I 124 evuzamitide for diagnosing cardiac amyloidosis in participants with suspected cardiac amyloidosis compared to clinical standard of truth diagnosis based on available clinical data. Secondary analyses assessed diagnostic performance in ATTR and AL subtypes. The imaging test used in this study was a positron emission tomography (PET) scan.
Participants received a single intravenous dose of I 124 evuzamitide, followed by cardiac and partial-body PET/CT imaging, 3-5 hours post-injection. All PET/CT images were independently read by experienced cardiac PET physicians, assessing visual presence or absence of cardiac tracer uptake, blinded to clinical data.
Cases were confirmed through an independent clinical adjudication committee, blinded to PET results, with expertise in cardiology, amyloidosis, and/or cardiac imaging. The committee established standard of truth using diagnostic data collected up to 60 days after imaging.
About Cardiac Amyloidosis
Cardiac amyloidosis is a severe, progressive disease caused by the accumulation of misfolded proteins (amyloid) in heart tissue, making it stiff and thick, which can impair its ability to pump blood effectively.5 Despite increasing disease awareness by health care providers, a prolonged diagnostic journey is common, with patients often consulting several specialists and receiving multiple tests and procedures before an accurate diagnosis.3
About Molecular Imaging
Molecular imaging allows clinicians to visualize and quantify biological processes at the molecular and cellular level in real time, enabling earlier disease detection and personalized treatment planning.6
About Radiology at Bayer
Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
ko (2026-0128E)
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260830902078/en/
Contacts:
U.S. contact for media inquiries:
Elaine Colón
Phone: +1-732-236-1587
Email:elaine.colon@bayer.com
Global contact for media inquiries:
Anna Koch
Phone: +49 30 2215-41595
Email: anna.koch@bayer.com
Find more information at www.bayer.com.
Source: Bayer
© 2026 Canjex Publishing Ltd. All rights reserved.