- With a focus on improving mitochondrial health, CNM-Au8® stands out among other therapies by targeting the nicotinamide adenine dinucleotide pathway to restore and protect neurological function.
- Nearly 2 million Americans are affected by amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”) or Parkinson’s disease.
- The global therapeutics markets for neurogenerative diseases are projected to grow substantially, driven by the growing prevalence of these conditions, rising geriatric population and the emergence of new therapies.
- Clene is preparing Phase 3 trials of CNM-Au8 in MS and ALS.
Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, is making significant strides with its lead candidate, CNM-Au8. This innovative treatment focuses on targeting the nicotinamide adenine dinucleotide (“NAD+”) pathway, which is critical for many mitochondrial functions, including energy production and redox homeostasis. Through this novel mechanism, CNM-Au8 restores and protects neurological function, offering new hope for patients with conditions like amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”) and Parkinson’s disease.
The potential market impact of CNM-Au8 is considerable, given the prevalence of these disorders. Approximately 5,000 Americans are diagnosed with ALS each year, and about 30,000 people are currently living with the disease in the U.S. alone, according to CDC statistics (https://ibn.fm/iMM9N). The global market for ALS therapeutics was valued at $537.2 million in 2018 and is expected to grow at a compound annual growth rate (“CAGR”) of 5.8% from 2019 to 2026, driven by increasing awareness, rising geriatric population and increasing incidence rate (https://ibn.fm/MgLWn). According to the National Institute of Neurological Disorders and Stroke, following gradual paralysis, patients with ALS often die from respiratory failure within 3-5 years.
MS, affecting nearly 1 million Americans and an estimated 2.9 million people worldwide, represents an even larger market. MS is a chronic disease that impacts the central nervous system, leading to a wide range of neurological symptoms. The MS therapeutics market is expected to grow significantly, expanding from $25.94 billion in 2023 at a CAGR of 5.9% from 2024 to 2030, fueled by advancements in treatment options and increased diagnostic rates (https://ibn.fm/ZHca3).
Parkinson’s disease, another key target for CNM-Au8, affects nearly 1 million people in the U.S., with 90,000 new cases diagnosed annually, and more than 10 million people worldwide (https://ibn.fm/UhyZV). The global Parkinson’s therapeutics market was valued at $4.28 billion in 2021 and is expected to expand at a CAGR of 12.1% from 2022 to 2030, driven by the increasing geriatric population, which is exposed to a high risk of developing Parkinson’s and the strong product pipeline of disease-modifying therapies (https://ibn.fm/lDbUs).
The potential of CNM-Au8 in these markets is underscored by its mechanism of action. CNM-Au8 works by improving cellular energy production and utilization, crucial for maintaining neuronal health. Mitochondrial dysfunction is a common pathway leading to neuronal death in neurodegenerative diseases. By targeting this dysfunction, CNM-Au8 aims to provide neuroprotection and promote remyelination, potentially altering the course of these debilitating conditions, providing a dual benefit that could distinguish it from existing therapies.
Clene’s advancement in this field comes at a time when the demand for innovative treatments is surging. The company is now seeking FDA feedback on a potential pathway for accelerated approval for ALS with CNM-Au8, while preparing for Phase 3 clinical trials in both ALS and MS. Driven by encouraging results in clinical trials so far and a robust safety profile with no serious adverse effects, Clene is well-positioned to make significant strides in this therapeutic landscape.
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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