Clene announces peer-reviewed publication on CNM-Au8

Clene 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 innovative and impactful research with translational relevance across a broad spectrum of biological sciences. The publication, led by Morteza Mahmoudi, associate professor in the Precision Health program and Department of Radiology at the Michigan State University College of Human Medicine, and members of his laboratory, fully characterized the proteins from human blood plasma that form the protein corona of the gold nanocrystals of CNM-Au8, an investigational drug in development for the treatment of neurodegenerative diseases. CNM-Au8 is comprised of a suspension of clean-surfaced, faceted gold nanocrystals that, once swallowed, pass through the gastrointestinal tract, and enter the body’s circulatory system, where they interact with, and become coated by, blood proteins and other biomolecules, forming the ‘protein/biomolecular corona.’ Using multiple state-of-the-art techniques that have been refined and optimized by the Mahmoudi lab, the group characterized the CNM-Au8 nanocrystals’ protein corona and made several important observations: Protein corona-coated CNM-Au8 nanocrystals are less likely to aggregate than the non-coated nanocrystals. The specific apolipoproteins that are enriched on the surfaces of CNM-Au8 nanocrystals are known to bind to specific receptors on the blood-brain barrier and promote the transport of substances across the BBB. The protein corona did not show a significant increase in complement proteins and fibrinogens compared to these proteins’ relative amounts in human plasma; coupled with the enrichment of apolipoproteins in these coronas, this corona composition is likely to increase colloidal stability and decrease inflammatory reactions from immune cells, consequently extending their circulation time in the blood. A Phase 3 registrational clinical trial of CNM-Au8 for the treatment of the progressive neurodegenerative disease, amyotrophic lateral sclerosis, is presently planned to launch in 2024.