There aren’t many of us with MS who haven’t had conversations about the cost of DMTs. The wholesale price of these powerful, life-changing drugs can be many factors to the average annual wage.
Sometimes it feels like the medicines we take should be made of gold or something…and now it is one.
Actual gold in MS medicine
The test compound, which includes a suspension of actual eight-sided gold nanocrystals, is called 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 preliminary findings at the American Academy of Neurology (AAN) meetings in Boston recently, the phase II study showed promising results.
Although the COVID-19 pandemic cut the expected study group in half (73 participants instead of 150 planned), Dr. Barnett and his team felt comfortable submitting their results for review. All subjects – including those who received the study drug and those who received placebo – had multiple sclerosis and chronic optic neuropathy as a condition of study entry.
Optic neuropathy is damage to the optic nerve, which is the nerve at the back of the eyeball that transmits visual information from your eye to the brain, allowing you to see.
Visual benchmarking and other functions
Focusing (no pun intended) on the low-contrast letter acuity test (LCLA), which measures levels of ocular (ocular) function, researchers saw an improvement of 3.13 letters in the treatment group compared to the placebo group in the study. This is a rather big increase.
The 48-week trial, called Visionary-MS, showed potential improvement in other aspects of living with multiple sclerosis.
Using a modified MS Functional Composite (MSFC) test tool as a procedure, the team measured upper limb and lower limb function as well as visual acuity. Overall scores for those receiving the active treatment improved by nearly 4 points (versus 0.7 points for the placebo group).
How does gold improve measures of MS?
The mechanism by which the test drug is believed to work is that the tiny tiny pieces of gold — small enough to pass through the gut into the circulation — prevent axon deterioration and may promote remyelination, possibly preserving the normal function of neurons.
It is important to note that this trial was seen as another layer on the existing MS treatments. Nearly all patients in both groups were already on DMT, and all were allowed to continue their current treatment during the study.
Did the drug preserve myelin?
Another positive outcome for this phase of the research was a significant increase in the electrical activity of the optic nerve for participants who got the active treatment, compared to those who got a placebo.
Barnett also suggested that myelin integrity was preserved in the active subjects during the trial and hinted that the level of remyelination may have outpaced disease-induced demyelination.
The results in patients with multiple sclerosis were so remarkable that another study was conducted, working alongside them, in patients with amyotrophic lateral sclerosis (ALS). This study did not have the same positive results.
Because this was a relatively small Phase 2 study (even smaller than proposed, as you mentioned, due to COVID-19), more research is needed before a treatment can be approved.
Clene Nanomedicine, the drug’s manufacturer, has not established protocols for the Phase III study. As always, we’ll wait and hope this is the breakthrough we’ve all been anticipating for so many years.
I suppose we’ll also have to wonder how much an MS drug made of actual gold would cost…
I wish you and your family the best health.
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