Clene Nanomedicine shared early results of the VISIONARY-MS trial, suggesting that CNM-Au8 — an investigational remyelinating therapy — leads to “notable” trends in better vision, as well as benefits in mobility and manual function in relapsing multiple sclerosis (MS) patients with chronic vision problems.
These findings were presented during the Joint NAIMS-IMSVISUAL Symposium at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020, running Feb. 27–29 in Florida, by Robert Glanzman, MD, Clene’s chief medical officer.
His presentation is titled “VISIONARY-MS Study: Phase 2 Design Rationale, Baseline Data, and Interim Blinded Results.“
It consists of a solution of gold (Au) nanoparticles with a patented crystal structure that act to support important energy-related reactions within cells, a process that Clene calls nanocatalysis.
By doing so, CNM-Au8 is designed to increase energy reserves within neurons and myelin-producing cells (oligodendrocytes), while decreasing toxic metabolic byproducts. This process is expected to improve neuronal survival and function, and to support the ability of oligodendrocytes to create new myelin.
Preclinical tests in mice demonstrated that CNM-Au8 stimulates the production of new myelin, and increases the number of myelin-wrapped nerve fibers in the brain and spinal cord, allowing animals to recover motor skills.
VISIONARY-MS (NCT03536559) is an ongoing Phase 2 trial investigating the efficacy and safety of CNM-Au8 as a remyelinating and neuroprotective treatment for adults with vision problems as a result of replacing MS, which includes relapsing-remitting and secondary progressive disease.
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