Enigma Biomedical USA Selects 4R Tau PET Biomarker Candidate
Enigma Biomedical USA, Inc. (EB USA) has announced the selection of two four-repeat tau (4R Tau) protein PET imaging biomarkers to advance into Phase 1 (Ph1) studies. This milestone follows EB USA’s execution of an Exclusive License and Option Agreement with AbbVie for the development and potential commercialization of AbbVie’s next-generation F18 PET imaging biomarkers. These biomarkers aim to assess the presence of 4R Tau in individuals suspected of having neurodegenerative diseases. Given the crucial role of misfolded 4R Tau protein in conditions such as Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration, these imaging tools could significantly enhance the understanding and diagnosis of tauopathies.
Advancing to Phase 1 Clinical Studies
Preclinical evaluations successfully identified two promising candidates for Phase 1 studies. These studies will assess several key parameters, including safety, dosimetry, biomarker dynamic uptake, washout rates, and optimal imaging time points. The initial clinical trials are scheduled to begin in the third quarter of 2025 (3Q25), marking a significant step toward potential clinical applications.
Rick Hiatt, President and CEO of EB USA, emphasized the significance of this development: “We are delighted to have advanced this program to the clinical stage. EB USA is dedicated to accelerating promising technologies to combat neurodegenerative diseases. Our experience with best-in-class neuroimaging biomarkers, such as MK-6240 (Cerveau Technologies, sold to Lantheus Medical Imaging in 2023) and NAV-4694 (developed by Meilleur Technologies Inc., sold to Lantheus in 2024), positions us well to develop these new 4R Tau PET imaging biomarkers from AbbVie. These biomarkers have unique properties and could be instrumental in the development of therapeutic agents for neurodegenerative diseases. Our goal is to broaden access to this novel investigational imaging technology for the wider scientific community.”
Scientific Significance and Research Goals
Dr. Hartmuth Kolb, Chief Science Officer of EB USA, highlighted the next steps in the research process: “We are excited to progress to the next phase of this critical development. The Phase 1 studies are designed to evaluate multiple characteristics of these candidate biomarkers beyond safety and dosimetry. This includes analyzing metabolite formation, tracer uptake, retention, and clearance dynamics.”
A key aspect of the research involves selecting the final candidate biomarker based on its effectiveness in distinguishing PSP patients from healthy individuals. The selection process will also consider factors such as the extent of off-target and non-specific binding, dynamic range, sensitivity, and tracer kinetics. The ultimate goal is to ensure the biomarker provides accurate and reliable data that can support the development of targeted therapies for tauopathies.
“We look forward to administering these candidate biomarkers later this year,” added Dr. Kolb. “Our research aims to refine imaging techniques that will aid in the early detection and better understanding of tau-related neurodegenerative diseases. This work could have a profound impact on both diagnostic strategies and treatment development.”
The Broader Impact of PET Imaging Biomarkers
PET imaging biomarkers have become increasingly important tools in neurodegenerative disease research. By enabling the visualization of pathological processes in the brain, they provide crucial insights into disease progression and therapeutic efficacy. 4R Tau protein accumulation is a defining feature of several tauopathies, and the ability to accurately image these deposits could lead to earlier and more precise diagnoses.
EB USA’s efforts to develop novel PET imaging biomarkers align with the broader industry trend of leveraging advanced imaging technologies to improve patient outcomes. These biomarkers could serve as valuable assets in clinical trials for emerging therapies, helping researchers assess treatment effectiveness in real time. If successful, they could be integrated into routine diagnostic protocols, significantly enhancing the standard of care for patients with neurodegenerative disorders.
About Enigma Biomedical USA, Inc.
Enigma Biomedical USA, Inc.’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. EB USA’s neuroimaging biomarkers provide Pharma and Academic researchers with best-in-class tools for enabling Disease-Modifying Therapy development with the highest possible precision and accuracy.
