- Neurodegenerative diseases pose a significant challenge in healthcare, yet treatment options remain limited
- CNM-Au8(R) has demonstrated remarkable efficacy across various nervous system cell types, with its ability to target fundamental deficiencies associated with dying neurons
- Gold nanocrystals found in CNM-Au8 act as miniature mitochondria, providing neurons with much-needed ATP energy while simultaneously converting toxic reactive oxygen species into harmless compounds
Neurodegenerative diseases pose a significant challenge in healthcare, yet treatment options remain limited. Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, is working on a potentially groundbreaking nanomedicine called CNM-Au8® that aims to revolutionize the approach to addressing nervous system failure associated with these debilitating conditions.
CNM-Au8 has demonstrated remarkable efficacy across various nervous system cell types, including oligodendrocytes, motor neurons, dopaminergic neurons, hippocampal, and cortical neurons. Its effectiveness has been validated in cellular and animal models of amyotrophic lateral sclerosis (“ALS”), Parkinson’s Disease (“PD”), and multiple sclerosis (“MS”).
CNM-Au8 achieves widespread efficacy due to its ability to target fundamental deficiencies associated with dying neurons: mitochondrial dysfunction, energy metabolic deficits, and toxic levels of oxidative stress. At the heart of CNM-Au8 lie catalytically active gold particles, meticulously engineered to be about 100th the size of mitochondria. Unlike many chemically synthesized gold nanoparticles, which can exhibit toxicity, CNM-Au8’s patented electrochemical crystal growth techniques ensure high catalytic activity while minimizing harm to living organisms. These gold nanocrystals act as miniature mitochondria, providing neurons with the much-needed energetic molecule ATP while simultaneously converting toxic reactive oxygen species into harmless compounds.
The groundbreaking potential of CNM-Au8 is evident in its application across various neurodegenerative diseases. In ALS, where motor neurons suffer from mitochondrial deficits and oxidative stress, CNM-Au8 has shown promising results in prolonging survival and slowing disease progression in clinical trials. In MS, where the immune system attacks neurons’ protective myelin sheath, CNM-Au8 has demonstrated improvements in visual impairments and cognitive deficits.
The company recently discussed the VISIONARY-MS trial, which was designed to investigate the protection or improvement of neurological function in stable relapsing-remitting MS participants with chronic optic neuropathy. The trial was a Phase 2 multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) versus placebo over 48 weeks of double-blind treatment.
The primary outcome was low contrast letter acuity (“LCLA”) improvement, a measure of vision using a modified eye chart for people with optic neuritis caused by their Multiple Sclerosis. Global neurological improvement, measured by the modified Multiple Sclerosis Functional Composite (“mMSFC”), a comprehensive measure of vision (eyesight), cognition (thinking ability), upper extremity function (fine motor muscle movement in the hand), and walking speed assessment was the secondary outcome. The trial successfully met both primary and secondary analyses in the prespecified intent-to-treat population, which had to be modified to accommodate an early trial conclusion brought about by the COVID 19 pandemic. Nearly all participants (92%) were treated with highly effective immunomodulatory disease modifying therapies (“DMTs”) as background standard of care. This meant that the benefits observed in the treatment group were benefits that occurred above and beyond the action of the approved treatments taken by participants.
In the double-blind portion of the trial, 73 participants were randomized, with 55 of 69 eligible (80%) participants continuing in the open label long-term extension (“LTE”) of the trial. Clene announced results from the open label long-term extension in early January 2024, demonstrating that the visual and cognitive benefits observed during the double blind period translated to continued improvements in all treated individuals for the duration of the LTE (nearly 2 years from the end of the double blind period, when all participants transitioned to active drug) (https://ibn.fm/O163z).
Benjamin Greenberg, M.D., Head of Medicine at Clene said that despite advances in immunotherapies for MS, there is a significant unmet need for treatments to prevent neurodegeneration and create opportunities for clinical improvement, and that years have been spent investigating neuroprotective therapies for multiple sclerosis and other neurodegenerative diseases.
“These data continue to build a strong case in favor of pursuing CNM-Au8 in upcoming Phase 3 studies. Clinically significant improvement is rarely seen in MS patients and this trial provides evidence of CNM-Au8’s potential to improve function in this population,” said Dr. Greenberg. “Clene is currently reviewing these data with prospective pharmaceutical partners interested in MS.”
These encouraging outcomes position CNM-Au8 as a frontrunner in neurodegenerative disease treatment. As we look forward to 2024, all eyes are on Clene Nanomedicine’s innovative drug, poised to deliver further breakthroughs in the fight against these devastating conditions.
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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