Novel gold therapeutic linked to improved outcomes in relapsing MS at 48 weeks

Key takeaways:

• Researchers analyzed data from 73 persons in the VISIONARY-MS trial treated with an oral suspension of gold adjunctive to DMTs.
• At week 48, BC-LCLA score improved significantly compared with placebo.

Treatment with an oral suspension of active gold as an adjunct to disease-modifying therapy was linked to improved neurological function in those with stable relapsing MS, according to a poster presented at ECTRIMS 2023.

“CNM-Au8, an oral suspension of catalytically active gold nanocrystals, supports brain energy metabolism resulting in neuroprotection and remyelination in preclinical models,” Heidi Beadnall, MBBS, FRACP, consultant neurologist at the Brain and Mind Centre, the University of Sydney, and colleagues wrote.

In the phase 2 multicenter, randomized, double-blind, placebo-controlled VISIONARY-MS clinical trial, researchers sought to assess safety and efficacy of CNM-Au8 treatment on patients with stable relapsing MS aged 18 to 55 who were also receiving background disease-modifying therapy (DMT), 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 greater than 70 mm in both eyes.

Their study examined CNM-Au8 compared with placebo over 48 weeks in 73 participants with stable relapsing MS, randomly assigned 1:1:1 to receive either CNM-Au8 15 mg per day, 30 mg per day or placebo. The primary outcome was change in BC-LCLA score in the clinically most affected eye to week 48, whereas secondary outcomes assessed global neurological function measured with the modified MS Functional Composite (mMSFC) to week 48. The study ended prematurely because of pandemic challenges with analysis of 73 participants out of 150 planned.

According to results, primary BC-LCLA outcome LS-mean difference was 3.13 (95% CI, –0.08 to 6.33), with significant secondary outcomes in two of three modes: LS-mean difference of mean standardized mMSFC score: 0.28 (95% CI, 0.04-0.52), and LS-mean difference of mMSFC average ranked sum score: 13.4 (95% CI, 2.8-23.9).

Treatment emergent adverse events were transient and only mild-to-moderate in severity.

“These data provide evidence for improved neurological function in stable [relapsing] MS patients treated with CNM-Au8 adjunctively to [disease-modifying therapies],” Beadnall and colleagues wrote.

Editor's Note: The article was corrected to clarify Beadnall's place of employment.