Neuraly and Enigma Biomedical have signed an agreement for PMI04, a positron emission tomography (PET) imaging biomarker for neuroinflammation.

Enigma will acquire an exclusive research license for the biomarker and the option for negotiating commercialisation rights based on the research findings.

Developed by Neuraly, PMI04 is tailored to ‘selectively bind’ to colony-stimulating factor 1 receptor (CSF-1R) in activated microglia, enabling the visualisation of neuroinflammatory responses. This is crucial for the diagnosis of neurodegenerative diseases such as Parkinson’s disease, multiple sclerosis, and Alzheimer’s disease.

Enigma’s development efforts will utilise PMI04 to assess these diseases.

Upon successful research outcomes, both companies will establish a licence agreement, granting exclusive rights to Enigma for developing and commercialising PMI04. Neuraly will obtain upfront and milestone payments, as well as future sales royalties.

Neuraly CEO Seulki Lee said: “We will do our utmost to ensure that PMI04 is commercialised swiftly through close collaboration with Enigma.”

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PET imaging methods targeting translocator protein (TSPO) currently face specificity challenges, complicating interpretation and quantitative assessment.

Neuraly noted that PMI04’s specificity to CSF-1R offers a direct correlation with microglial activity, making it a promising biomarker for quantifying inflammation-related neurodegenerative diseases.

Enigma CEO and president Rick Hiatt said: “We are delighted to have been selected as a development partner by Neuraly. We will build on demonstrated successes with the best-in-class neuroimaging biomarkers MK-6240 (Cerveau Technologies) and NAV-4694 (Meilleur Technologies).

“We believe the Neuraly CSF-1R PET imaging biomarker has unique properties and will prove useful in developing current and future therapeutics for neurodegenerative disease. Our commitment is to expand the availability of this novel investigational imaging agent to the broader scientific community.”

Neuraly focuses on investigational new drug (IND)-enabling studies and clinical development for diseases, including neurodegenerative, metabolic, and fibrotic conditions.