Clene’s CNM-Au8 Shows Promising Results in ALS Treatment as NIH-funded Expanded Access Program Progresses
SALT LAKE CITY, May 28, 2024 - Clene Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine Inc. have announced significant updates regarding their National Institutes of Health (NIH)-funded Accelerating Access to Critical Therapies Expanded Access Program (ACT-EAP) for CNM-Au8. As a clinical-stage biopharmaceutical company dedicated to improving mitochondrial health and protecting neuronal function in neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), Clene’s progress in their CNM-Au8 compassionate use program for ALS patients presents promising developments.
ALS, often referred to as Lou Gehrig’s disease, is a devastating neurodegenerative disorder that leads to the degeneration of motor neurons. Currently, there is no cure for the disease, and available treatments only modestly slow its progression. Recognizing the urgent need for effective therapeutics, Clene has been granted NIH funding to initiate the ACT-EAP to evaluate the potential of CNM-Au8 in treating ALS patients.
CNM-Au8 is an orally-delivered suspension of clean-surfaced, catalytically-active gold nanocrystals. Extensive research has shown that CNM-Au8 possesses significant neuroprotective and neuroreparative properties in various preclinical models of neurodegenerative diseases. Clene’s recent publication in a peer-reviewed journal detailed the mechanism of action of CNM-Au8, highlighting its ability to engage with specific targets in the brain, thus further confirming its potential as a promising therapeutic candidate.
These peer-reviewed findings have sparked tremendous enthusiasm within the scientific community as they unveil the pharmacological potential of CNM-Au8. Driven by this momentum, Clene has made significant progress in their ACT-EAP, bringing hope to ALS patients who previously had limited treatment options. The compassionate use program aims to provide these patients with access to CNM-Au8 while the clinical trial process continues.
Clene’s update on the ACT-EAP showcases the successful implementation of the program, ensuring patients in need can benefit from CNM-Au8’s potential therapeutic effects. By expanding access to this groundbreaking treatment, Clene reinforces its commitment to providing innovative solutions for neurodegenerative diseases.
With the promising progress seen thus far, Clene anticipates considerable momentum in their ALS treatment program. The company’s dedication to improving mitochondrial health and protecting neuronal function underscores its mission to revolutionize treatment options for neurodegenerative diseases.
As Clene’s research and development efforts gain recognition and their commitment to advancing CNM-Au8 reaches new heights, the future holds exciting prospects for ALS patients and the broader scientific community.

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