- Clene, a late clinical-stage biopharmaceutical company, creates clean-surfaced, catalytically active nanocrystals that directly modulate biological systems, including the central nervous system, by improving mitochondrial health
- The company’s lead investigational candidate, CNM-Au8(R), is currently in development as a disease-modifying treatment for people living with specific types of neurodegenerative disorders (“ND”), namely amyotrophic lateral sclerosis (“ALS”), Parkinson’s Disease, and multiple sclerosis (“MS”)
- Neurodegenerative disorders are characterized by neurodegeneration – the progressive loss of neuron structure, neuronal functions, and finally, the neurons themselves
- Nanotherapeutics are in development to stop or reverse neurodegeneration using novel approaches to address the mitochondrial deficits and bioenergetic crises common to these neurodegenerative diseases
Also known simply as nerve cells, neurons are central to most – if not all – of the body’s normal functions, from breathing and talking to eating, thinking, and walking (https://ibn.fm/zWMUR). They support these activities by sending and receiving information between the brain and muscles, and are also responsible for receiving sensory input from the external environment and relaying that information to the brain.
As crucial as neurons are, they are not immortal. Like all other cells in the body, nerve cells undergo apoptosis, which is the programmed process by which body cells die. Apoptosis helps remove surplus, aged, damaged, or unwanted cells. However, in some cases, apoptosis becomes dysregulated, leading to the premature loss of central nervous system cells (https://ibn.fm/DqqvW) as is seen in neurodegeneration.
“Diseases with neurodegeneration as their hallmark feature are collectively termed as neurodegenerative disorders (‘NDs’). The most common NDs include Alzheimer’s disease, Parkinson’s disease, prion disease, amyotrophic lateral sclerosis (‘ALS’), motor neuron disease, Huntington’s disease, spinal muscular atrophy, and spinocerebellar ataxia,” explains a 2022 study (https://ibn.fm/qldhY).
While NDs affect millions worldwide and continue to be a growing concern, their treatment have only utilized small molecule or biologic approaches. More progress is needed as a number of challenges remain, ranging from lack of efficacy to lack of delivery of sufficient amounts of active drug to the brain across the blood brain barrier.
Fortunately, in recent years, nanotechnology has revolutionized the healthcare sector, facilitating the development of nano-sized therapeutic drugs or nanotherapeutics. These nanotherapeutics, whose sizes range between 1 and 100 nm, are positioned as a possible alternative for stopping or reversing neurodegeneration thanks to their unique mechanisms of action and their potential ability to efficiently cross the blood-brain barrier without altering or damaging it.
The therapeutic potential of nanoparticles has piqued the interest of Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on the discovery and development of innovative, life-changing medicines for people with serious and life-threatening diseases. The company has created and refined a proprietary electro-crystallization-method that results in clean-surfaced, catalytically active nanocrystals that directly modulate biological systems, including the central nervous system, by improving mitochondrial health.
“Multiple lines of evidence now point to energetic failure as a key contributor to neurodegenerative disease. Neurons and their associated support cells, in particular oligodendrocytes, are amongst the highest energy-consuming cells in the body: the brain represents only 2% of the human body weight, yet it consumes over 20% of the body’s metabolic energy. As humans age, our cell’s ability to convert food into energy in the form of ATP becomes less efficient. Eventually, the nervous system’s demand for ATP surpasses the cell’s ability to supply it, and as a consequence, neurons begin to fail and subsequently die,” explains the company in its 2022 annual report (https://ibn.fm/QsZVY).
Clene’s preclinical studies have shown that its lead investigational candidate CNM-Au8, an oral suspension of clean-surfaced, catalytically-active gold nanocrystals, crosses the blood-brain barrier and gives the neurons and associated support cells an energetic boost or helps improve energy production and utilization to enhance survival. The preclinical studies eventually transitioned into clinical studies, which have demonstrated promising results.
Recently, the company reported a 75% decreased risk of death, and a statistically significant 52% decreased risk of ALS clinical worsening events (defined as first occurrence of any of the following: death, tracheostomy, assisted ventilation, or feeding tube placement) in ALS clinical trial participants treated with CNM-Au8 following long-term analysis. A separate long-term follow-up analysis also showed that treatment with CNM-Au8 significantly improved survival in ALS patients (https://ibn.fm/Ne9PJ). Because individuals diagnosed with ALS typically live an average of 3-5 years beyond their diagnosis, a drug that has potential to affect lifespan garners great interest, especially if the drug is shown to be safe with minimal side effects. To date, Clene has reported over 500 years of human subject exposure without any serious adverse events attributed to the drug across all its clinical programs.
CNM-Au8 is currently in development as a disease-modifying treatment for people living with ALS, Parkinson’s Disease, and MS. ALS is an ND that affects motor neurons, the neurons in the brain and spinal cord that control breathing and voluntary muscle movements, causing these nerve cells to degenerate and die. Parkinson’s Disease is caused by the death of nerve cells that produce dopamine. These cells are located in the basal ganglia, an area of the brain that controls movement. As a result, Parkinson’s Disease patients experience unintended or uncontrollable movements and difficulty with coordination and balance. MS is a disorder in which the immune system cells attack and eat away at the substance that covers the nerves known as myelin. In MS, multiple neuronal subtypes can be affected by demyelination, and subsequently die as a result of myelin loss. In all of these diseases, studies have shown that mitochondrial dysfunction precedes neuronal death. By targeting mitochondrial function with the innovation of catalytically-active gold nanocrystals, Clene aims to develop a first-in-class drug to address these diseases with few treatment alternatives and significantly high unmet needs.
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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