Clene Announces Peer-Reviewed Publication Characterizing the Protein Corona of the Investigational Neurodegenerative Disease Drug, CNM-Au8

• Proprietary catalytic gold nanocrystals comprising Clene’s investigational drug CNM-Au8 develop a protein corona upon exposure to human blood plasma comprised of proteins that promote blood-brain barrier penetration, an important feature of the drug’s neuroprotective mechanism of action
  
  
• The protein corona attracted by CNM-Au8 nanocrystals prevents aggregation upon entering the bloodstream, enabling the drug’s longevity in circulation without provoking an inflammatory response
  

SALT LAKE CITY, March 15, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) 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 (ALS) and multiple sclerosis (MS), today 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 (apolipoproteins A-I, A-II, C-II, C-III, and E) are known to bind to specific receptors on the blood-brain barrier (BBB) and promote the transport of substances across the BBB.