CNM-Au8 is an experimental treatment being tested in multiple sclerosis patients in clinical trials. The oral, drinkable medication is designed to increase energy reserves and help clear toxic substances resulting from the metabolism of nerve cells and oligodendrocytes, the cells that produce the myelin coating that is damaged in MS. This disease-modifying therapy is expected to protect nerve cells and boost myelin production by oligodendrocytes.
Phase 2 trials in CNM-Au8 have shown promising results in adults with relapsing forms of multiple sclerosis. Clene, the therapy’s developer, extended one of these trials to include people in non-active progressive disease. While these trials are expected to conclude in late 2022, Phase 3 trials will be needed to confirm the treatment’s safety and efficacy in these patient populations. Thus, it is still too early to know if or when the medication might be approved by the U.S. Food and Drug Administration.
Clinical trials of CNM-Au8 have excluded patients who are pregnant, breastfeeding, or planning to become pregnant during the studies or within six months after treatment discontinuation. Therefore, it is not known if the treatment is safe for use during pregnancy.
Some patients in clinical trials have seen benefits within about three months. In Phase 2 clinical trials involving individuals with relapsing forms of multiple sclerosis, CNM-Au8 treatment resulted in a significant increase in energy metabolism, as well as significant improvements in vision and physical abilities, within 12 weeks of treatment initiation.
Hair loss and weight gain have not been reported in clinical trials as side effects of CNM-Au8. Patients should talk with their care team if they experience any unexpected side effects during treatment.
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