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Clene Inc. (NASDAQ: CLNN) Continues Development of Lead Drug Candidate CNM Au8(R) for Neurodegenerative Diseases including Parkinson’s Disease

  • CNM-Au8 is an oral suspension with demonstrated activity in restoring neuronal health and function by increasing energy production and utilization
  • Treatment with CNM-Au8 investigated in clinical trials adjunctive to standard-of-care exhibits no known drug interactions, and aims to enhance function and survival
  • Nearly 90,000 people are diagnosed with Parkinson’s disease every year with no approved drug to slow or halt disease progression currently available
  • The Parkinson’s disease treatment market was valued at $4.61 billion in 2022 and is expected to reach $11.98 billion by 2030

In recognition of April as Parkinson’s Disease Awareness Month, IBN is highlighting Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including Parkinson’s disease (“PD”), amyotrophic lateral sclerosis (“ALS”), and multiple sclerosis (“MS”). Clene is developing its lead drug candidate CNM-Au8(R) for potential treatment of these neurodegenerative diseases. CNM-Au8 is an oral suspension designed to restore neuronal health and function by increasing energy production and utilization by driving critical cellular energy-producing reactions that enable neuroprotection and remyelination. The result is an increase in neuronal and glial resilience to disease-relevant stressors.

In March 2021, Clene was awarded a grant from The Michael J Fox Foundation for Parkinson’s Research (“MJFF”) to accelerate the development of CNM-Au8 as a treatment for PD. The funding supports efficacy studies in a human cell culture model of PD that utilizes skin cells from individuals with PD. The cells are then converted in the laboratory to dopaminergic neurons that exhibit many aspects of the disease state. The research, led by Karen Ho, PhD, VP Translational Medicine at Clene, was a collaboration with Dr. Jerome Mertens while he was Assistant Professor at the University of Innsbruck (currently Associate Professor in the Department of Neurosciences of the University of California, San Diego) and is currently a collaboration with Dr. Fred (“Rusty”) Gage, Vi and John Adler Chair for Research on Age-Related Neurodegenerative Disease, Professor of Genetics of the Salk Institute. These two scientists are world-renowned researchers who pioneered the specific techniques to generate the human cell model utilized for the project. The team is exploring multiple aspects of the effects of CNM-Au8 on PD neurons, including potential improvements in mitochondrial function and effects on transcriptomic profiles in comparison to untreated healthy and disease controls. Results from the study are expected in Q2 2024.

The peer-reviewed publication, “Evidence of brain target engagement in Parkinson’s disease and multiple sclerosis by the investigational nanomedicine, CNM-Au8, in the REPAIR phase 2 clinical trials,” was published in Journal of Nanobiotechnology in December 2023 (https://link.springer.com/article/10.1186/s12951-023-02236-z). The study demonstrated that oral daily doses of CNM-Au8 over 12 weeks leads to increased levels of brain metabolites associated with improved mitochondrial function and brain health in these diseases.

Over 600 cumulative years of CNM-Au8 patient exposure across ALS, MS, and PD trials and compassionate use programs have shown no safety concerns. With safety, early efficacy, and brain target engagement data in hand for PD, Clene is advancing CNM-Au8’s development as a potential first-in-class treatment for PD.

A Parkinson’s Foundation-backed study in 2022 found that nearly 90,000 people are diagnosed with Parkinson’s disease every year – which is approximately the amount of fans at the Rose Bowl Stadium. This number represents a 50% increase from the previous estimated rate of 60,000 diagnoses annually.

“These updated estimates of incidence are necessary for understanding disease risk, planning health care delivery, and addressing care disparities,” said James Beck, Ph.D., Parkinson’s Foundation Chief Scientific Officer (https://nnw.fm/86eOO). “Knowing this information will allow us to better serve people with Parkinson’s and their families and plan for adequate health care services in the future.”

The Parkinson’s disease treatment market was valued at $4.61 billion in 2022. It is expected to grow at a CAGR of 12.1%, resulting in an estimated value of $11.98 billion by 2030. The market’s growth is supported by the increasing geriatric population, the high burden of Parkinson’s disease in Western countries, and the strong product pipeline of disease-modifying therapies. It is estimated that Parkinson’s disease affects around 1% of the total population aged 60 years and older and rises to 5% for 85 years and older (https://nnw.fm/OmSX9).

CNM-Au8(R) is a federally registered trademark of Clene Nanomedicine, Inc.

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://nnw.fm/CLNN

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