- Clene is developing a new class of drugs that hold the potential to transform the lives of millions suffering from debilitating conditions such as Amyotrophic Lateral Sclerosis (“ALS”), Multiple Sclerosis (“MS”), and Parkinson’s Disease (“PD”)
- CNM-Au8(R), Clene’s lead drug candidate, is a fundamentally new approach for treating the underlying factors contributing to ALS, MS, and PD, by restoring neuronal health and function
- ALS, the most prevalent adult-onset progressive motor neuron disease, affects approximately 30,000 people in the U.S.
Clene (NASDAQ: CLNN), a pioneering biopharmaceutical company, is making significant strides in the treatment of neurodegenerative diseases through its novel nanotherapeutic platform. With a mission to improve underlying mitochondrial health and protect neuronal function, Clene is developing a new class of drugs that hold the potential to transform the lives of millions suffering from debilitating conditions such as Amyotrophic Lateral Sclerosis (“ALS”), Multiple Sclerosis (“MS”), and Parkinson’s Disease (“PD”).
At the forefront of Clene’s innovations is CNM-Au8, a gold nanocrystal suspension currently in development. CNM-Au8 is designed to act as a treatment for ALS, MS, and PD by restoring neuronal health and function. The drug works by increasing cell energy production and utilization, driving critical cellular reactions that promote neuroprotection and remyelination, thereby enhancing neuronal and glial resilience to disease-related stressors.
In a recent Xtalks podcast, Clene discussed the significant developments of CNM-Au8 and its unique technology. CNM-Au8’s mechanism of action involves the conversion of critical energetic metabolites within living cells to produce ATP, the essential energy currency for cellular functions. The gold nanocrystals attract a coating of apolipoproteins from human plasma, facilitating their passage through the blood-brain barrier and into the brain, where they can protect neurons from death and repair damaged neurons by catalyzing energy production (https://ibn.fm/Gvb5o).
CNM-Au8 is being evaluated in multiple clinical trials, including the prestigious Harvard/MGH HEALEY ALS Platform Trial, which targets patients with mid-to-late stage ALS. The drug has also completed the RESCUE-ALS proof-of-concept clinical trial for early symptomatic ALS, and the REPAIR trials, showing promising changes in brain energy metabolites with CNM-Au8 administration. Additionally, CNM-Au8 has completed a clinical trial, VISIONARY-MS, for treating visual pathway deficits in chronic optic neuropathy, demonstrating its potential for remyelination in stable relapsing MS.
With more than 650 estimated years of collective exposure across ALS, MS, and PD participants in CNM-Au8 clinical trials and Expanded Access Protocol (compassionate use) programs, CNM-Au8 has shown a robust safety profile without any observed safety signals. The drug is designed to be used in combination with other agents and has no known drug-drug interactions, making it a versatile option for patients.
ALS, the most prevalent adult-onset progressive motor neuron disease, affects approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide. Clene estimates that global ALS treatment sales will exceed $1 billion annually in the coming years, underscoring the urgent need for viable treatment options.
Founded in 2013 and based in Salt Lake City, Utah, Clene Inc. is at the forefront of developing innovative treatments for neurodegenerative diseases. With research and development, as well as manufacturing operations in Maryland, Clene is committed to transforming the treatment landscape for ALS, MS, PD, and other debilitating conditions through its groundbreaking nanotherapeutic platform.
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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