The senior academic at the University of Sydney provided perspective on the promising findings of the phase 2 VISIONARY-MS study of CNM-Au8 in relapsing multiple sclerosis. [WATCH TIME: 6 minutes]
WATCH TIME: 6 minutes
"There’s this big unmet need because demyelination, or failure of remyelination, drives gradual axonal attrition. That’s thought to be one of the principal factors underpinning disease progression in patients with MS who have no overt inflammatory activity either clinical or in MRI."
Developed by Clene Nanomedicine, CNM-Au8 is an investigational, oral suspension of clean-surfaced, catalytically-active gold nanocrystals currently in development for the treatment of conditions such as amyotrophic lateral sclerosis, multiple sclerosis (MS), and Parkinson disease. The agent is being assessed in a phase 2, double-blind, placebo-controlled study called VISIONARY-MS (NCT03536559), which features adults with stable relapsing MS with less than 15 years of disease duration. Patients included also had best corrected-low contrast letter acuity (BC-LCLA) using 2.5% low-contrast Sloan letter chart of 20/40 or worse in the affected eye and mean retinal nerve fiber layer thickness of at least 70 mm in both eyes.
Presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27, in Boston, Massachusetts, the study used change in BC-LCLA score in the clinically most effected eye at week 48 as the primary end point. At the conclusion of the analysis, the least-square mean difference in BC-LCLA between patients on active treatment and placebo was 3.13 (95% CI, –0.08 to 6.33; P = .056). In addition, 2 of the 3 key secondary outcomes were significant: LS-mean difference of mean standardized modified MS Functional Composite (mMSFC) score (0.28; 95% CI, 0.04-0.52; P = .0197) and LS-mean difference of mMSFC average ranked sum score (13.4; 95% CI, 2.8-23.9; P = .0138).
At the meeting, NeurologyLive® sat down with lead investigator Michael Barnett, PhD, MBBS, FRACP, senior academic at the University of Sydney, to discuss the data presented. Barnett provided insight on the notable findings from the trial, the history of gold nanocrystals in medicine, and the change in MS drug development as therapeutics become more advanced.
Click here for more coverage of AAN 2023.