Bayer Acquires Pan-Amyloid Imaging Agents from Attralus to Advance Cardiac Amyloidosis Diagnosis
核心洞察
Bayer has acquired two investigational molecular imaging agents, AT-01 and AT-05, from Attralus (搜索) to enhance early diagnosis of cardiac amyloidosis (搜索), a rare and often fatal heart disease affecting an estimated 400,000 people globally.
AT-01, a PET tracer in Phase III development, is the first pan-amyloid (搜索) imaging agent to receive FDA Breakthrough Therapy Designation for cardiac amyloidosis (搜索), while AT-05 is a SPECT tracer in Phase I development.
The acquisition marks Bayer's strategic entry into diagnostic tracers and reinforces its expansion in the rapidly growing molecular imaging market, valued at approximately $3 billion in 2024.
Bayer has entered into definitive agreements to acquire two investigational molecular imaging agents from Attralus (搜索), Inc., marking the pharmaceutical giant's strategic entry into diagnostic tracers and reinforcing its expansion in the rapidly growing field of molecular imaging. The acquisition includes AT-01 (124-Iodine-evuzamitide (搜索)) and AT-05 (PAR-Peptide + technetium-99m (搜索)), both designed for the diagnosis of cardiac amyloidosis (搜索).
Strategic Expansion into Molecular Imaging
"With this strategic acquisition and the integration of novel molecular tracers into our development portfolio, we are advancing Bayer's innovation strategy," said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of Bayer's Pharmaceuticals Division. "AT-01 and AT-05 are precisely engineered to detect cardiac amyloidosis (搜索) with high accuracy, enabling timely intervention and improved patient outcomes – a clear extension of our commitment to tackling cardiovascular disease and addressing significant unmet needs."
The acquisition supports Bayer's broader precision cardiology strategy and leverages the company's expertise in medical imaging, including its pipeline and portfolio in advanced fluid delivery devices for nuclear medicine. The global market for radio-diagnostic tracers was valued at approximately $3 billion in 2024 and is projected to grow significantly in the coming years.
Advanced Imaging Technologies for Underdiagnosed Disease
AT-01 (124-Iodine-evuzamitide (搜索)) is a non-invasive pan-amyloid (搜索) PET imaging agent specifically designed for accurate diagnosis of amyloid disease, including in the heart. The compound utilizes a proprietary pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific radiotracer to detect all types of systemic amyloidosis (搜索) using PET imaging. In clinical trials, AT-01 has been observed to detect multiple types of amyloid deposits with high sensitivity and specificity, including ATTR (transthyretin amyloid cardiomyopathy (搜索)) and AL (light chain amyloidosis (搜索)), in major organs such as the heart, kidney, liver, and spleen.
AT-01 holds the distinction of being one of the first investigational diagnostic imaging agents to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (搜索), and the only diagnostic imaging agent that has received BTD for cardiac amyloidosis (搜索). The compound has also received orphan drug designation as a diagnostic for the management of ATTR and AL amyloidosis in both the U.S. and EU. The Phase III study REVEAL with AT-01 in patients with suspected cardiac amyloidosis is ongoing and has completed dosing.
AT-05 (PAR-Peptide + technetium-99m (搜索)) is a Single Photon Emission Computed Tomography (SPECT) tracer currently in Phase I development, representing an additional diagnostic option using SPECT technology that could broaden patient access.
Addressing Critical Diagnostic Gaps
Cardiac amyloidosis (搜索) is a spectrum of diseases caused by the abnormal build-up of amyloid (搜索) protein in heart tissue. These deposits accumulate between heart cells, making the heart muscle thick and stiff, preventing effective blood pumping and leading to heart failure (搜索) and heart rhythm problems. Advanced stages can result in cardiomyopathy (搜索), and the condition may be an underlying factor in a relevant portion of patients with heart failure.
The development of these tracers addresses the urgent need for earlier and accurate diagnosis of systemic and specifically cardiac amyloidosis (搜索), a rarely diagnosed and often fatal heart disease that affects an estimated 400,000 people globally. With current methods, these conditions are often underdiagnosed and difficult to detect. Clinical recognition at an early stage is important for adequate and effective patient management with existing therapeutic options, as the disease is often diagnosed late when amyloid (搜索) accumulation has already occurred and patients have irreversible loss of heart function and diminished quality of life.
Strategic Partnership Benefits
"We are excited to finalize this agreement with Bayer, whose expertise and global footprint in radiology will help to accelerate the development and launch of AT-01 and AT-05, our two novel diagnostic imaging agents for systemic amyloidosis (搜索)," said Glen Firestone, President of Attralus (搜索). "Despite recent progress in systemic amyloidosis, most patients continue to remain undiagnosed or are diagnosed too late in their disease progression."
Nelson Ambrogio, President Radiology at Bayer, emphasized the acquisition's significance: "With new therapies emerging for often insufficiently treated conditions such as cardiac amyloidosis (搜索), it becomes increasingly relevant to precisely detect and monitor diseases on the molecular level. This acquisition marks our entry into diagnostic tracers."
Following the acquisition, Attralus (搜索) will focus on advancing its innovative pan-amyloid (搜索) removal therapeutics, with AT-02 in Phase II and next generation candidates in preclinical development. The financial details of the acquisition were not disclosed.
Market Position and Future Outlook
Bayer's comprehensive portfolio in radiology, expertise in medical imaging and clinical development, and global commercial infrastructure position the company to accelerate innovation and deliver integrated offerings that address evolving clinical needs. In 2024, Bayer's radiology products generated €2.1 billion in sales, and the company continues to advance research and innovation in medical imaging, including molecular imaging.
The acquisition aligns with Bayer's existing cardiovascular portfolio, which includes Beyonttra™ (acoramidis) for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (搜索) (ATTR-CM), and compounds in various stages of preclinical and clinical development.