- Clene is pioneering a very unique approach to the treatment of neurodegenerative diseases such as ALS and MS with the use of an oral nanotherapeutic that can be easily administered
- The company has submitted CNM-Au8 biomarker and efficacy data to the Food and Drug Administration in a Type C meeting request, seeking approval to file a new drug application using the accelerated approval pathway for ALS
- CNM-Au8 has the potential to impact the ALS therapeutic market, as CNM-Au8 can help increase and improve survival rates and delay clinical worsening in ALS patients
- In MS, CNM-Au8 can work in conjunction with current treatments to improve vision, cognition, and global neural function in MS patients, potentially capturing a significant portion of the MS market as well
Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, was recently featured on The BioMedWire Podcast, highlighting the important results of CNM-Au8 trials for both amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), and plans for the future (https://nnw.fm/hVRJS).
During the podcast, CEO Rob Etherington explained that Clene is focused entirely on improving mitochondrial health and protecting neuron function, which is “the most important thing we can do to treat neurodegenerative diseases such as ALS, MS, and Parkinson’s.”
Etherington added that having safe and effective therapies to improve function in neurodegenerative disease patients is essential and topical, as the World Health Organization is predicting that neurodegenerative diseases will become the second-most prevalent cause of death within the next two decades. “We’re pioneering a very unique approach: the use of an oral suspension that patients can drink to treat the deficits that they might have if afflicted with one of these devastating neurodegenerative diseases,” he said.
In fact, this approach is one of the key things that set Clene apart from the competition, Etherington said. “Nobody else has theorized that you can drink an oral nanotherapeutic, and that it would do two specific things: improve the mitochondrial dysfunction that is endemic with these diseases, and improve or increase the nicotinamide adenine dinucleotide pathway which is compromised in neurodegenerative diseases.”
Etherington also explained that there is an exigent need for effective therapies for ALS and MS that can improve function, which is something CNM-Au8 has been shown to do in several clinical trials.
“ALS is historically known as Lou Gehrig’s disease, famously named after the baseball player who contracted it in the 1930s. From there, it took 60 years for the first ALS drug to be approved by the FDA, approved in 1995 and still remains today, nearly three decades later, the standard of care. There’s obviously a tremendous need for new drugs in ALS. In the case of multiple sclerosis, there are a lot of drugs that can treat MS, but they all do effectively the same thing: they tamp down the body’s immune response, so the body stops attacking itself. What they don’t do is improve function – the way patients move and walk and talk and think cognitively with MS,” he said.
CNM-Au8 hopes to capture a significant share of the $26 billion therapeutic market for MS, by working in conjunction with existing treatments to enable the energetic capacity that patients’ neurons require to function. In the case of ALS, where the therapeutic market is considerably smaller, CNM-Au8 can help increase and improve survival rates and delay disease progression.
Clene recently announced results of two independently conducted Phase 2 clinical trials, RESCUE-ALS and HEALEY ALS Platform Trials, where participants saw improvement in survival rates and delays in clinical worsening, defined as first occurrence of death (or death and permanent assisted ventilation), tracheostomy, need for invasive ventilatory support, or feeding tube placement. Previous studies investigating CNM-Au8 for MS (Repair-MS and Visionary-MS) also showed significant improvement in global neurological function and vision in stable MS patients, Etherington said.
The company has submitted CNM-Au8 biomarker and clinical efficacy data to the Food and Drug Administration in a Type C meeting request, seeking approval to file a New Drug Application (“NDA”) using the accelerated approval regulatory pathway for ALS. A response is expected in the third quarter of 2024. If this accelerated pathway is approved, the next steps will be to file an NDA by the end of the year and to launch a confirmatory global Phase 3 study in ALS.
Etherington also discussed CNM-Au8’s potential as a treatment for other neurodegenerative diseases, including Parkinson’s, Rett syndrome, frontal temporal dementia and Huntington’s, explaining that the drug’s mechanism of action could benefit patients with these conditions as well. The company is also looking at potentially expanding into other disease areas with other therapies once it begins commercializing CNM-Au8, the Clene CEO added.
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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