Clene Nanomedicine, Inc.

A therapeutic pipeline based on clean-surfaced nanocrystal technology

Surmounting evidence points to a decline in the brain’s ability to produce energy as a key driver of neurodegeneration. Unfortunately, the last few decades have made little headway in addressing nervous system disorders. This is likely because of the typical one-drug one-target approach used in traditional small molecule drug development. In contrast, clean-surfaced nanocrystals act on multiple mechanisms to enhance a cell’s energetic ability while simultaneously reducing oxidative stress and stimulating protein homeostasis inside nervous system cells. 

Clene Inc. has pioneered CSN by uniting concepts from electrochemistry, plasma and quantum physics, nanotechnology, material science, and biochemistry. Inside the body, CSN therapeutics are able to cross cellular membranes and enter cells in order to donate and receive electrons within biological systems. CSNs can drive, support, and help maintain beneficial metabolic and energetic reactions within diseased, stressed, and damaged cells. Each nanocrystal can exchange thousands of electrons each second to improve cellular performance. 

CSN therapeutics can be administered orally or through aqueous suspensions, whereby they are able to accumulate in critical organs like the kidneys, liver, and spleen. They are also able to cross the blood-brain barrier to reach the brain, spinal cord, and cerebrospinal fluid for beneficial therapeutic effects. These nanocrystals can remain active within the body for multiple days before they are safely passed out by the body’s waste removal systems. 

Clene’s leading product candidate is CNM-Au8. CNM-Au8 is an oral delivery of pure gold nanocrystals in pharmaceutical grade water buffered with sodium bicarbonate. The therapy works through the heat shock protein-1 pathway in nervous system cells to boost NAD+ activity and increase ATP. It also reduces ROS, or reactive oxygen species, to avoid the destruction of cell structures due to oxidative stress.  

CNM-Au8 for ALS

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder of the neuromuscular system that causes muscle weakness and paralysis, eventually leading to death within approximately 3 to 5 years of diagnosis. It’s estimated that around 31,000 people are living with ALS in the United States and approximately 5,000 new patients are diagnosed each year. Although the FDA has approved three drug therapies to treat ALS, none of these treatments have been found to substantially halt or reverse the disease. 

CNM-Au8 for the treatment of ALS is currently undergoing phase 2 clinical trials, with a potential international phase 3 on the horizon. The therapy’s neuroprotective properties have shown the ability to slow the progressive degeneration of motor neurons associated with ALS. CNM-Au8 for the treatment of ALS also has an orphan drug designation from the FDA.

CNM-Au8 for MS

Multiple sclerosis (MS) is an inflammatory and degenerative disorder of the central nervous system that causes the destruction of the brain, spinal cord, and optic nerves. MS patients experience motor symptoms, cognitive disability, and visual impairment. MS affects approximately 1 million people in the United States, with women three-times more likely to receive the diagnosis than men. Although there are currently disease-modifying therapies available to treat MS, these either treat only the symptoms of the disease or reduce the degree of inflammation. 

CNM-Au8 for the treatment of MS is currently undergoing phase 2 clinical trials. The therapy’s ability to support neuroprotection and remyelination to improve cellular energy has shown positive results in clinical studies. 

CNM-Au8 for PD

Parkinson’s disease (PD) is a progressive neurodegenerative disorder characterized by the progressive loss of dopaminergic neurons in the midbrain, which is the main source of dopamine in the central nervous system. This leads patients to experience symptoms like resting tremors, limb rigidity, cognitive loss, and behavioral changes. It’s estimated that Parkinson’s affects between 500,000 to 1 million people in the United States, costing $14 billion annually in treatment. The currently available treatments for Parkinson’s focus on symptomatic improvement and none are able to prevent the destruction of dopaminergic neurons. 

CNM-Au8 for the treatment of PD is currently undergoing phase 2 clinical trials and has been shown capable of being neuroprotective of dopaminergic neurons. 

Operational overview

Clene Inc. has yet to have any product candidates make it through the research and development stage to commercial approval and therefore has generated no revenue from drug product sales. However, the company does earn marginal revenue related to supply agreements for dietary supplements. Even so, the company has incurred substantial losses since inception. To continue operations and progress its drug candidates, Clene expects to raise additional funding in the form of further equity offerings, debt financings, or licensing and collaboration agreements with third parties. 

Conclusion

Clene Inc. is innovating a new type of therapy never seen before with its clean-surfaced nanotechnology. The company protects its valuable intellectual property related to its drug candidates and the processes used to produce them with a portfolio of over 150 patents issued globally. To further safeguard its trade secrets, Clene also conducts all research and development activities in house. Although Clene has significant hurdles to overcome in order to reach profitability, the company’s leading product candidate has made impressive progress towards commercialization. If CNM-Au8 is approved for commercial sale for any of the mentioned medical indications being targeted, the profit potential is substantial.

There’s still considerable uncertainty surrounding clean-surfaced nanotechnology. However, the therapy has shown promising results thus far and it has a fair shot of improving healthspan by serving as an upgraded treatment option for neurodegenerative disorders.