Experimental Medications: Administered Orally

Company: Clene Nanomedicine

  • Oral medication being studied at up to 30 mg per day
  • Being studied in RMS

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Researchers are investigating the efficacy and safety of the oral suspension medication CNM-Au8 for repairing central nervous system damage in people with relapsing forms of MS (RMS) who experience visual impairment.

A Phase II clinical trial is under way, with full results expected in mid-2021. Preliminary results showed a median improvement in visual function among 34 patients across 36 weeks, based on performance on the Low Contrast Letter Acuity (LCLA), a vision test for individuals with MS. Physical and cognitive function also improved, based on several patient surveys commonly used to measure MS-related functional decline.

Preliminary results also indicate that CNM-Au8 is safe and well tolerated. All reported adverse events (AEs) were mild in severity, with headache, upper respiratory infection, and sore throat being the most commonly reported AEs with either the 15 mg per day or 30 mg per day dosage, according to the company developing the medication.70, 71

CNM-Au8 consists of nanocrystalline gold particles formulated to promote normal cellular function while decreasing abnormal, destructive activity. It is hoped that this treatment approach will not only prevent further damage to myelin (the protective sheath surrounding neurons), but will repair previously damaged myelin and, in the process, restore lost function in MS.70

In preclinical studies, CNM-Au8 prolonged survival of nerve cells in the central nervous system and showed effectiveness in regenerating myelin. CNM-Au8 also showed safety and tolerability in Phase I studies that involved healthy volunteers. Clene Nanomedicine, the biopharmaceutical company developing CNM-Au8, has received FDA approval to conduct clinical studies of this experimental medication for reversing remyelination failure in patients with MS.70