Enigma Biomedical USA, Inc. Announces Candidate Selection of Novel 4R Tau PET Imaging Biomarkers

KNOXVILLE, Tenn.--(BUSINESS WIRE)--Enigma Biomedical USA, Inc. (EB USA) today announced that it has selected two (2) four-repeat tau (4R Tau) protein PET imaging biomarkers to advance into Phase 1 (Ph1) studies. Previously, EB USA executed an Exclusive License and Option Agreement (License) with AbbVie for the development and potential commercialization of AbbVie’s next-generation F18 PET imaging biomarkers to assess the presence of 4R Tau in subjects with suspected neurodegenerative disease. These imaging biomarkers hold great promise as important new tools in advancing understanding of a range of neurodegenerative diseases in which the misfolded 4R Tau protein is implicated, including the tauopathies Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration.

Preclinical evaluations successfully identified two candidates to advance to Ph1 studies. These studies will examine several parameters, including safety, dosimetry, biomarker dynamic uptake and washout as well as determination of the optimal time for imaging. The studies are projected to commence in 3Q25.

“We are delighted that we have progressed this program to the clinical stage,” said Rick Hiatt, President and CEO of EB USA. “EB USA is committed to enabling the acceleration of promising technologies to advance the fight against debilitating neurodegenerative diseases. In this, we will build on demonstrated successes with the best-in-class neuroimaging biomarkers MK-6240 (Cerveau Technologies, sold to Lantheus Medical Imaging in 2023) and NAV-4694 (in development by Meilleur Technologies Inc., sold to Lantheus in 2024.) We believe our 4R Tau PET imaging biomarkers from AbbVie have unique properties and will prove useful in developing therapeutic agents in neurodegenerative disease. Our goal is to expand the availability of this novel investigational imaging technology to the broader scientific community.”

Hartmuth Kolb, Ph.D., Chief Science Officer of EB USA, states: “EB USA is excited to take the next steps in this important development process. The Ph1 studies are designed to measure an array of candidate characteristics in addition to safety and dosimetry, including metabolite formation and the dynamics of tracer uptake, retention and clearance. A final candidate for future development will be chosen based on increased uptake in PSP patients relative to that of healthy controls, the extent of off-target and non-specific binding as well as dynamic range, sensitivity and kinetics. We look forward to the first administration of these candidate biomarkers later this year.”

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.