There aren’t many of us with multiple sclerosis (MS) who haven’t had conversations about the cost of MS disease-modifying therapies (DMTs). The wholesale price of these powerful and life-changing drugs can be many factors of the average annual wage.
Sometimes it seems like the drugs we’re taking must be made of gold or something … and now one is.
Actual Gold in an MS Medication
The test compound, which includes a suspension of eight-sided nanoscale crystals of actual gold, is dubbed CNM-Au8 for the purposes of this research. (Au is the chemical symbol for gold on the periodic table of chemistry.)
According to Michael Barnett, PhD, a professor of neurology at the University of Sydney in Australia, who reported initial findings at the American Academy of Neurology (AAN) meetings in Boston recently, the phase 2 study is showing promising results.
Although the COVID-19 pandemic reduced their anticipated study cohort by half (73 participants instead of a planned 150), Dr. Barnett and his team felt comfortable in sending their findings on for review. All of the subjects — including those who received the study drug and those who received the placebo — had both multiple sclerosis and chronic optic neuropathy as a condition of enrollment in the study.
Optic neuropathy is damage to the optic nerve, the nerve in the back of the eyeball that transfers visual information from your eye to the brain, allowing you to see.
Visual and Other Functioning Measured
Focusing (no pun intended) on the low-contrast letter acuity (LCLA) test, which measures levels of ocular (eye) function, investigators saw an improvement of 3.13 letters in the treatment group relative to the placebo group in the study. That is a fairly significant increase.
The 48-week trial, called Visionary-MS, also showed possible improvement in other aspects of living with multiple sclerosis.
Using a modified MS functional composite (MSFC) test instrument as a measure, the team measured upper-limb and lower-limb function as well as visual acuity. Overall scores for those on active therapy improved by nearly 4 points (versus 0.7 points for the placebo group).
How Does Gold Improve MS Measures?
The mechanism by which the test drug is thought to work is that the extremely small bits of gold — small enough to pass through the alimentary tract into circulation — block axonal degradation and might even promote remyelination, possibly preserving nerve cells’ normal function.
It’s important to note that this trial was seen as being another layer to existing MS treatments. Nearly all of the patients in both groups were already on a DMT, and all were allowed to continue their current treatment during the study.
Did the Drug Preserve Myelin?
Another positive outcome of this phase of the research showed marked increase in electrical activity of the optic nerve of participants who got the active treatment, compared with those who got a placebo.
Barnett also suggested that the integrity of active subjects’ myelin was preserved during the trial and hinted that a level of remyelination might just have outpaced demyelination caused by the disease.
The results on MS patients were so marked that another study, operating in tandem, on patients with amyotrophic lateral sclerosis (ALS) was undertaken. This study did not have the same positive results.
As this was a relatively small (even smaller than proposed, as I mentioned, due to COVID-19) phase 2 study, further research is required before the therapy might be approved.
Clene Nanomedicine, the maker of the drug, has not yet set out protocols for a phase 3 study. We will, as ever, wait and hope that this may be the breakthrough we’ve all been anticipating for so very many years.
I suppose we’ll also have to wonder what an MS drug made of actual gold is going to cost …
Wishing you and your family the best of health.
Cheers,
Trevis
