Key Takeaways
Bayer announced on May 7 that its investigational PET tracer, I 124 evuzamitide, met both primary endpoints in a Phase III study for diagnosing the progressive and underdiagnosed heart condition, cardiac amyloidosis.
"These I 124 evuzamitide data demonstrate the potential of a single test to help health care providers identify or exclude cardiac amyloidosis," said Dr. Sharmila Dorbala, Director of Nuclear Cardiology at Brigham and Women’s Hospital and the study's principal investigator.
The investigator-initiated REVEAL study, sponsored by Brigham and Women’s Hospital, successfully met its primary endpoints of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation. The multicenter, open-label trial evaluated 170 adults with suspected cardiac amyloidosis, comparing the tracer's diagnostic performance to the clinical standard of care. Bayer confirmed it plans to present the complete results at an upcoming scientific congress.
The positive outcome is a significant step for a condition that can take two to four years to diagnose from symptom onset and affects an estimated 400,000 patients worldwide. The tracer, also known as AT-01 and acquired from Attralus, Inc., previously received Breakthrough Therapy Designation from the FDA, potentially expediting its path to market.
Cardiac amyloidosis is caused by the buildup of misfolded proteins in heart tissue, leading to stiffness that can impair the heart's ability to pump blood, often resulting in heart failure. Currently, no single, non-invasive test can reliably detect and diagnose the disease.
"As a leader in radiology, we are committed to bringing forward options for earlier diagnosis of diseases such as cardiac amyloidosis for the benefit of patients," said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. The acquisition of evuzamitide is part of Bayer's strategy to build a leading position in imaging for cardiovascular conditions.
The successful Phase III data positions Bayer to begin discussions with the FDA and other global health authorities for regulatory approval. A new, effective diagnostic could significantly improve outcomes for a growing patient population by enabling earlier and more accurate treatment. Investors will now watch for the full data presentation and the initiation of regulatory filings.
This article is for informational purposes only and does not constitute investment advice.
