- The publication provides a comprehensive analysis of proteins from human blood plasma that interact with CNM-Au8(R)
- CNM-Au8 nanocrystals coated with a protein corona are less prone to clumping compared to those without any coating
- Certain apolipoproteins found on the nanocrystals’ surface, which aid in crossing the blood-brain barrier (“BBB”), were identified, suggesting an enhanced delivery mechanism into the brain
- The findings enrich the understanding of CNM-Au8’s mechanism as preparations for a Phase 3 trial for ALS are underway, scheduled for the second half of 2024
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently reported the publication of “Protein Corona Composition of Gold Nanocatalysts” in the journal ACS Pharmacology & Translational Science, a journal of the American Chemical Society that publishes research with translational relevance across a broad spectrum of biological sciences (https://ibn.fm/JPS7Z).
A research team led by Morteza Mahmoudi, an associate professor at Michigan State University’s Precision Health program and Department of Radiology, along with his lab members, have provided a comprehensive analysis of proteins from human blood plasma that interact with the gold nanocrystals of CNM-Au8(R), a drug currently under investigation for treating neurodegenerative conditions.
CNM-Au8 consists of clean-surfaced gold nanocrystals that are ingested and absorbed into the bloodstream, where they bond with proteins and other biomolecules to form what is known as a ‘protein/biomolecular corona’. Utilizing advanced techniques perfected by Prof. Mahmoudi’s lab, the researchers were able to detail the makeup of this protein corona around CNM-Au8 nanocrystals, making several key discoveries:
- CNM-Au8 nanocrystals coated with this protein corona are less prone to clumping compared to those without any coating
- Certain apolipoproteins found on the nanocrystals’ surface, which aid in crossing the BBB, were identified, suggesting an enhanced delivery mechanism into the brain
- The composition of the protein corona, notably lacking in enrichment of complement proteins and fibrinogens but enriched for specific apolipoproteins, suggests improved stability in suspension and reduced potential for immune response, potentially lengthening their presence in the bloodstream
The study is available for review at https://pubs.acs.org/doi/full/10.1021/acsptsci.4c00028.
Prof. Mahmoudi highlighted the unique composition of the CNM-Au8 gold nanocrystals’ protein corona, particularly the enhanced presence of key apolipoproteins like apolipoprotein E, facilitating its passage through the BBB. The absence of certain proteins extends the nanocrystals’ bloodstream lifespan, aligning with clinical observations. This engineered structure, free of surfactants, aids in delivering the nanocrystals to brain tissue effectively.
Mark Mortenson, Chief Science Officer of Clene, reflected on the development of these gold nanocrystals, noting the initial focus on their catalytic properties but recognizing the significance of the protein corona in controlling the nanocrystals’ in vivo biodistribution. The findings support the beneficial properties of CNM-Au8 as a neuroprotective agent, corroborated by preclinical and clinical research outcomes.
Michael Hotchkin, Clene’s Chief Development Officer, reported consistency in the favorable effects of orally administered CNM-Au8 on brain metabolites in Phase 2 trials for MS and Parkinson’s disease. Safety and tolerability were confirmed across extensive trials, with the formation of the protein corona once in the bloodstream playing a crucial role in enhancing brain accessibility. The findings enrich the understanding of CNM-Au8’s mechanism as preparations for a Phase 3 trial for ALS are underway, scheduled for the second half of 2024.
For more information, visit the company’s website at www.Clene.com.
NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN
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