Novel gold therapeutic linked to improved outcomes in MS at 96 weeks
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Key takeaways:
- Treatment with the novel therapeutic led to remyelination and improved axonal function.
- Adverse events were mild to moderate, and six serious adverse events were recorded over 82.9 patient-years of follow-up.
DENVER — Daily treatment with a suspension of gold crystals was linked to improved outcomes at 96 weeks for those with stable relapsing multiple sclerosis, according to a speaker at the American Academy of Neurology annual meeting.
“This is an oral suspension of gold nanocrystals, approximately 1.2 quadrillion of them,” Michael Barnett, MBBS, PhD, clinical neurologist at the Brain and Mind Centre at the University of Sydney, said in his presentation.
Results from the double-blind portion of the VISIONARY-MS study found that the oral, investigational CNM-Au8 treatment improved low contrast letter acuity (LCLA) and global neurological function assessed by the modified MS Functional Composite (MSFC) compared with placebo in patients with stable relapsing MS on approved disease-modifying immunomodulatory therapies (DMTs).
In the long-term extension, Barnett and colleagues sought to determine safety, efficacy, tolerability and pharmacokinetics of CNM-Au8 30 mg in the same population over 96 weeks after completion of the 48-week double-blind period.
A total of 55 participants out of the 69 eligible received daily 30 mg doses of CNM-Au8. In addition to safety, functional endpoints were assessed at clinical visits every 12 weeks: LCLA for each eye by 2.5% Sloan letter chart, modified MSFC score including the Timed 25-Foot Walk (T25FWT), Symbol Digit Modality Test (SDMT), 9-Hole Peg Test (9HPT, dominant and non-dominant hands), and LCLA (both eyes).
According to results, the mean difference at week 144 for LCLA change across both eyes vs. the original randomization baseline of participants assigned to CNM-Au8 was +8.7 letters (1.88), 95% CI: 5-12.4 and SDMT change vs. the original randomization baseline of participants assigned to CNM-Au8 was +8.03 (1.52), 95% CI: 5.01-11.
Data also showed that improvements during the double-blind period were maintained in the LTE for SDMT, T25FWT and 9PHT, with substantial gains found in low contrast vision and cognition as well as in reduction of T2 lesion activity.
Treatment with CNM-Au8 was also safe and well-tolerated in the extension phase, with treatment-emergent adverse events mild to moderate. A total of six serious adverse events were recorded over 82.9 patient-years of follow up.
“(We) find not only paraclinical evidence of remyelination and improved axonal function, but measurable improvements in previously fixed clinical deficits both visual and global,” Barnett noted. “These results are particularly exciting.”