- Clene’s mission is to transform the treatment of neurodegenerative diseases with a new class of drugs, potentially impacting the lives of millions
- The company’s uniquely structured gold nanocrystals have the remarkable ability to convert critical energetic metabolites in living cells for the production of ATP, the essential energy currency for cellular functions, offering disease combatting capabilities
- Clene is currently preparing for Phase 3 clinical trials of CNM-Au8for ALS and MS, following successful early studies
Xtalks Life Science Podcast recently featured Karen S. Ho, PhD, Vice President of Translational Medicine for Clene (NASDAQ: CLNN), a late-stage biopharmaceutical company focused on protecting mitochondrial health and neuronal function to treat neurodegenerative diseases. In the episode, host Ayesha Rashid, PhD, discussed Clene’s innovative gold nanocrystal technology and how Dr. Ho is leading the company’s development in diseases like ALS (Amyotrophic Lateral Sclerosis), MS (Multiple Sclerosis), and PD (Parkinson’s Disease).
Clene’s mission is to transform the treatment of neurodegenerative diseases with a unique approach, potentially impacting the lives of millions. They are pioneering a new class of drugs that integrates principles from chemistry, physics, and material science, and applying these to biological systems.
At the forefront of their research is the development of catalytically active drugs, with their lead asset being CNM-Au8. This innovative compound employs gold nanocrystals, which are unique because gold, typically known for its inert properties, becomes highly catalytically active in its nanocrystal form if manufactured to be clean-surfaced and highly faceted. A single Clene gold nanocrystal has a structure similar to a faceted diamond, and is much smaller than a red blood cell in size. . Through special processing these nanocrystals can act as catalysts, aiding in the conversion of critical energetic metabolites in living cells into ATP, the essential energy currency for cellular functions. When suspended in water and consumed by patients, these nanocrystals can enter the bloodstream and also cross the blood-brain barrier to reach diseased brain cells. This is crucial for neurons afflicted by neurodegenerative diseases, which face a variety of stressors, including oxidative stress and mitochondrial dysfunction. These cells require additional energy input from ATP to combat these issues. By facilitating ATP production, these nanocrystals help neurons rebuild, protect themselves, and function optimally.
The gold nanocrystals act as catalysts for this energy production process, meaning they open pathways for energy production without themselves being consumed and used up. This remarkable property, requiring nanocrystals that are specially manufactured to avoid organic contamination, is vital in supporting many cellular functions, and shows strong potential for the treatment of various neurodegenerative diseases. Despite differing symptoms, these diseases share the common issue of dealing with energetically demanding neurons that suffer when mitochondrial function and energy production are compromised.
Traditional methods of producing gold nanocrystals involve organic chemicals that can adhere to the crystals’ surfaces, impeding their catalytic activity and potentially introducing biological toxicity. Clene has developed a superior method, using an electrocrystal chemistry to produce stable gold nanocrystal particles with clean, highly faceted surfaces, enhancing their catalytic activity.
In addition, recent research showed that these gold nanocrystals successfully attract a coating of apolipoproteins from human plasma that aids their passage through the blood-brain barrier. Therefore, when the gold nanocrystals are taken in by mouth, they travel through the gastrointestinal system and enter the bloodstream, where they attract apolipoproteins to aid their crossing of the blood brain barrier and get into the brain. Once in the brain the gold nanocrystals help protect neurons from death and repair damaged neurons by catalyzing energy production.
Clene is currently preparing for Phase 3 clinical trials of CNM-Au8 for ALS and MS. Phase 2 studies have already demonstrated that CNM-Au8 can significantly reduce the risk of death in ALS patients, who typically have a prognosis of 2-5 years. Additionally, Phase 2 studies on MS have shown notable improvements in cognition and vision, suggesting remyelination capabilities.
Clene’s ultimate goal is to obtain FDA approval for CNM-Au8, marking a significant milestone in their journey to introduce this groundbreaking treatment approach for neurodegenerative and other diseases, a huge market with significant unmet needs.
The podcast episode can be found at https://ibn.fm/v5bnE.
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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