Enigma Biomedical USA Selects Candidates for Novel 4R Tau PET Imaging Biomarke
Enigma Biomedical USA, Inc. has announced the selection of two novel four-repeat tau (4R Tau) protein PET imaging biomarkers for advancement into Phase 1 (Ph1) clinical studies. This significant milestone follows the company’s earlier partnership with AbbVie, where they executed an Exclusive License and Option Agreement (License) for the development of AbbVie’s next-generation F18 PET imaging biomarkers. These biomarkers are designed to assess the presence of 4R Tau in individuals suspected of having neurodegenerative diseases. The 4R Tau protein is implicated in several tauopathies, including Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration, both of which are characterized by misfolded tau proteins.
Partnership with AbbVie and License Agreement
In a move that paves the way for the advancement of these biomarkers, EB USA and AbbVie entered into an agreement to develop and potentially commercialize a new class of F18 PET imaging biomarkers. These biomarkers are focused on assessing the presence and accumulation of 4R Tau, a critical target in various neurodegenerative diseases. The collaboration marks a strategic step in developing advanced tools for understanding diseases like PSP and Corticobasal Degeneration, which currently lack definitive diagnostic methods. By advancing these biomarkers, EB USA aims to improve early detection and monitoring of these conditions, which is critical for developing therapeutic solutions.
Progressing to Phase 1 Clinical Studies
Following successful preclinical evaluations, EB USA has identified two promising candidates for further development and is advancing them into Phase 1 studies. The Phase 1 trials will focus on evaluating the safety and efficacy of the 4R Tau PET imaging biomarkers, including examining several important parameters:
- Safety: Assessing the overall safety profile of the biomarkers in human subjects.
- Dosimetry: Studying the appropriate dosages and potential exposure risks.
- Biomarker Dynamic Uptake and Washout: Understanding how the biomarkers behave over time, including their absorption and elimination from the body.
- Optimal Imaging Time: Determining the best time window for imaging to ensure accurate and efficient results.
These studies are projected to begin in the third quarter of 2025 (3Q25), marking an exciting next step in the journey toward advancing these biomarkers as diagnostic tools for neurodegenerative diseases.
Commitment to Advancing Neurodegenerative Disease Research
Rick Hiatt, President and CEO of EB USA, expressed his excitement about this significant milestone: “We are delighted that we have progressed this program to the clinical stage. EB USA is committed to enabling the acceleration of promising technologies to advance the fight against debilitating neurodegenerative diseases. This effort builds on our prior successes with neuroimaging biomarkers, such as MK-6240 (developed by Cerveau Technologies, sold to Lantheus Medical Imaging in 2023) and NAV-4694 (developed by Meilleur Technologies Inc., sold to Lantheus in 2024).
We believe our 4R Tau PET imaging biomarkers from AbbVie have unique properties and will be instrumental in developing therapeutic agents for neurodegenerative diseases. Our goal is to expand the availability of this novel investigational imaging technology to the broader scientific community.”
The company has demonstrated a strong track record in advancing cutting-edge neuroimaging biomarkers, which play a crucial role in understanding and diagnosing neurodegenerative diseases. By collaborating with AbbVie and advancing these 4R Tau biomarkers, EB USA aims to contribute to the development of new, more effective treatments for diseases like PSP and Corticobasal Degeneration.
Ph1 Study Design and Candidate Evaluation
Hartmuth Kolb, Ph.D., Chief Science Officer of EB USA, highlighted the significance of the Phase 1 studies: “EB USA is excited to take the next steps in this important development process. The Phase 1 studies are designed to measure a broad array of candidate characteristics, including safety, dosimetry, and dynamics of tracer uptake, retention, and clearance. We will also examine metabolite formation to better understand the behavior of these biomarkers in the body. Based on these parameters, a final candidate for further development will be selected. The key factors for selection include increased uptake of the biomarker in PSP patients compared to healthy controls, minimal off-target binding, and robust dynamic range, sensitivity, and kinetics.”
The Phase 1 studies will be crucial in determining which of the selected biomarkers shows the greatest promise for future development. This includes measuring the level of uptake in patients with PSP and comparing it to healthy individuals, as well as understanding the biomarker’s binding characteristics, sensitivity, and overall effectiveness.
Looking Ahead
The upcoming Phase 1 studies represent an important step toward the development of a reliable imaging tool for diagnosing and monitoring neurodegenerative diseases linked to 4R Tau. By advancing these biomarkers, EB USA hopes to provide clinicians with a powerful tool to detect and track the progression of tauopathies such as PSP and Corticobasal Degeneration, conditions that are difficult to diagnose in their early stages.
The progress of these biomarkers holds great promise not only for advancing the understanding of these diseases but also for accelerating the development of new treatments. As the field of neurodegenerative disease research continues to evolve, EB USA’s work with these 4R Tau PET imaging biomarkers could play a critical role in improving patient outcomes and offering hope to those affected by these debilitating conditions.
Conclusion
Enigma Biomedical USA’s selection of two 4R Tau PET imaging biomarkers for Phase 1 clinical studies marks a significant milestone in the development of diagnostic tools for neurodegenerative diseases. By advancing these biomarkers, EB USA is helping to pave the way for better understanding, earlier detection, and improved treatment options for diseases like Progressive Supranuclear Palsy and Corticobasal Degeneration. With a clear commitment to advancing neurodegenerative disease research, EB USA is poised to make meaningful contributions to the fight against these complex and challenging conditions.
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.
