Bayer's Investigational PET Tracer I-124 Evuzamitide Meets Primary Endpoints in Phase III Cardiac Amyloidosis Study
核心洞察
Bayer (搜索)'s investigational PET radiotracer I-124 evuzamitide (搜索) successfully met primary endpoints for sensitivity and specificity in diagnosing cardiac amyloidosis (搜索) in the Phase III REVEAL study.
The study evaluated 170 adults with suspected cardiac amyloidosis (搜索) across 19 U.S. centers, demonstrating the potential for a single non-invasive diagnostic test for this underdiagnosed condition.
I-124 evuzamitide (搜索) has received FDA Breakthrough Therapy Designation and Orphan Drug status, with Bayer (搜索) planning regulatory discussions for approval submission.
Bayer (搜索) announced positive topline results from the Phase III REVEAL study, demonstrating that its investigational PET radiotracer iodine 124 evuzamitide (搜索) (I-124 evuzamitide (搜索)) successfully met primary endpoints for diagnosing cardiac amyloidosis (搜索). The investigator-initiated study by Brigham and Women's Hospital showed the compound achieved both sensitivity and specificity targets for cardiac amyloidosis diagnosis based on visual scan interpretation.
The breakthrough addresses a critical unmet medical need, as cardiac amyloidosis (搜索) typically takes between 2-4 years from symptom onset to diagnosis, and currently no single, non-invasive test exists for reliable detection and diagnosis of the disease. The condition affects approximately 400,000 patients worldwide, though this number is likely underestimated due to frequent misdiagnosis.
Study Design and Results
The REVEAL ("Research with EVuzamitide I 124 to Elucidate Cardiac AmyLoidosis (搜索)") study was a multicenter, open-label, single-arm Phase III trial conducted at 19 centers across the United States, evaluating 170 adults with suspected cardiac amyloidosis. Participants received a single intravenous dose of I-124 evuzamitide (搜索), 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 who assessed visual presence or absence of cardiac tracer uptake while blinded to clinical data. Standard of care diagnosis was independently adjudicated by clinical amyloidosis experts, blinded to PET results, using routine diagnostic data collected up to 60 days after imaging. Diagnostic sensitivity and specificity of I-124 evuzamitide (搜索) were determined using standard of care diagnosis as the reference standard.
Secondary analyses assessed diagnostic performance in both ATTR (transthyretin amyloidosis (搜索)) and AL (light-chain amyloidosis (搜索)) subtypes, the two main forms of cardiac amyloidosis (搜索).
Clinical Significance
"Cardiac amyloidosis (搜索) is often under- or misdiagnosed, impacting patients' ability to begin appropriate treatment earlier, when it may help prevent further organ damage," said Dr. Sharmila Dorbala, Director of Nuclear Cardiology at Brigham and Women's Hospital and REVEAL principal investigator. "These I 124 evuzamitide data demonstrate the potential of a single test to help health care providers identify or exclude cardiac amyloidosis."
Dr. Dorbala emphasized that a sensitive, specific and quantitative PET tracer could help distinguish cardiac amyloidosis (搜索) from other causes of heart failure (搜索), differentiate amyloid (搜索) subtypes when used alongside appropriate laboratory testing, and track changes in cardiac amyloid burden over time.
Regulatory Status and Development
I-124 evuzamitide (搜索) has received significant regulatory recognition, including FDA Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis (搜索). The compound also holds Orphan Drug status for both light-chain amyloidosis (搜索) (AL) and transthyretin amyloidosis (搜索) (ATTR) in both the United States and European Union.
Bayer (搜索) plans to discuss the data and submission for regulatory approval with the FDA and other health authorities. The company will present complete results at an upcoming scientific congress.
Strategic Acquisition
I-124 evuzamitide (搜索), also known as AT-01, is one of two investigational amyloid (搜索) radiotracers that Bayer (搜索) acquired from Attralus, Inc. in early 2026. The acquisition expanded Bayer's radiology pipeline with complementary tracers targeting systemic amyloid disease and reinforced the company's strategy to build a leading position in precision imaging for cardiovascular and other serious conditions.
"As a leader in radiology, we are committed to bringing forward options for earlier diagnosis of diseases such as cardiac amyloidosis (搜索) for the benefit of patients," said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer (搜索)'s Pharmaceuticals Division.
Disease Background
Cardiac amyloidosis (搜索) is a severe, progressive disease caused by the accumulation of misfolded proteins (amyloid (搜索)) in heart tissue, making it stiff and thick, which impairs the heart's ability to pump blood effectively. Without appropriate diagnosis and treatment, cardiac amyloidosis can lead to heart failure (搜索), frequent hospitalizations and early mortality.
Despite increasing disease awareness among healthcare providers, a prolonged diagnostic journey remains common, with patients often consulting several specialists and receiving multiple imaging procedures before receiving an accurate diagnosis. The current diagnostic challenge stems from the lack of a single, non-invasive test that can reliably detect and diagnose cardiac amyloidosis (搜索) or quantify and monitor myocardial amyloid (搜索) burden.