- Clene has conducted five Phase 2 clinical trials, three with long-term extensions, and three expanded access programs (with additional studies ongoing) to evaluate the safety and efficacy of CNM-Au8
- The global ALS treatment market is poised for growth, driven by an aging population and limited current treatment options
- CNM-Au8 works by improving cellular energy production and utilization, which is crucial for maintaining neuronal health, and is at a deficit in neurodegenerative diseases
Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc. is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). In the recent Emerging Growth Conference 73 on July 17-18, 2024, CEO Rob Etherington and CFO Morgan Brown presented new findings and information about the company and its lead drug candidate, pertinent to current and potential investors.
In the opening of the presentation, Etherington explained that mitochondria play a vital role in cellular metabolism and energy production, and that impaired mitochondrial function is a significant issue in neurodegenerative diseases. Clene’s lead agent, CNM-Au8(R), works by improving cellular energy production and utilization via the nicotinamide adenine dinucleotide (NAD+) pathway, which is crucial for maintaining neuronal health. By addressing mitochondrial dysfunction, CNM-Au8 provides neuroprotection and promotes remyelination, potentially altering the course of debilitating neurodegenerative diseases. This innovative approach aims to restore and protect neurological function (https://ibn.fm/j7gYH).
CNM-Au8 is being investigated to treat neurodegenerative diseases in clinical studies and comprehensive compassionate use programs in ALS, MS, and even one study in Parkinson’s Disease, Etherington explained.
The Clene CEO also highlighted the strong safety profile of CNM-Au8, with over 650 years of cumulative subject exposure and no serious adverse events linked to the drug. Extensive clinical trials have been conducted to evaluate its safety and efficacy. Phase 2 trials for ALS have shown improved survival rates and delayed clinical worsening. Additionally, significant improvements in biomarkers and functional outcomes were observed.
The company is now preparing for Phase 3 studies for both ALS and MS, while seeking feedback from the Food and Drug Administration on a potential pathway for accelerated approval for CNM-Au8.
The global ALS treatment market is expected to grow significantly due to the increasing prevalence of the disease among the aging population. Grand View Research reports that the market is anticipated to reach $885.5 million by 2026, but the growth may be hindered by the high costs associated with ALS treatments (https://ibn.fm/cprPz).
According to Etherington, ALS is more common than thought, and treatment options are severely limited both in the United States and worldwide, making the potential impact of CNM-Au8 even more significant. Department of Health Resources & Services data indicate that the estimated prevalence of ASL in the U.S. was 5.2 per 100,000 people in 2015.
Etherington further noted that CNM-Au8’s ability to penetrate the blood-brain barrier and its neuroprotective properties make it a promising candidate not only for ALS and MS but also for other neurodegenerative diseases.
As the company continues to make significant strides in addressing critical unmet needs in the market, its innovative approach, robust intellectual property portfolio, and promising clinical data position Clene as a leading entity in the field of neurodegenerative disease treatment.
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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