The effects of multiple sclerosis can be devastating with research in how to treat the disease continually ongoing.
DHR Health is now taking part in that with their participation in a trial to examine the efficacy of a new medication versus the efficacy of a medication that has already been approved for the treatment of multiple sclerosis.
Dr. R. Alejandro Cruz at the DHR Health Neurology Institute is leading the study locally into that new medication.
The clinical trial is sponsored by Novartis Pharmaceuticals with 65 locations worldwide, according to the official registry of the trial.
The trial is meant to study the new drug, Remibrutinib, compared to Teriflunomide which has already been approved by the U.S. Food and Drug Administration.
“We want to confirm that this new medication is better than Teriflunomide, which is an FDA-approved medication, in reducing the frequency of multiple sclerosis relapses,” Cruz said.
Multiple sclerosis, MS, is a chronic disease that affects the brain and the central nervous system. It affects each person differently with some people experiencing only mild symptoms while others may lose the ability to write, speak or walk.
“Multiple sclerosis is a disease that patients will have attacks or relapses so this medication will be looking into decreasing the frequency of these relapses in (comparison) to Teriflunomide which is a medication that is already approved for MS that does work, also concerning relapses, so that’s the primary objective,” Cruz said.
Remibrutinib, the new drug, is a BTK inhibitor which means it targets and covalently binds to BTK (Bruton’s tyrosine kinase), blocking its activity.
“It is a very unique mechanism of action because it targets three different areas physiologically that we know that play a big role in the pathology of multiple sclerosis,” Cruz said. “Basically this medication will be basically targeting those pathways that we know are very involved in the inflammation that comes with MS, so it’s very exciting.”
The study is a double-blind study which means half of the participants will receive the already-approved drug, Teriflunomide, while the other half will receive the new drug, Remibrutinib.
What Cruz also finds exciting about this study is the inclusion of the Hispanic and Latino population which Cruz said is largely missing from data about MS.
With a trial site in the Rio Grande Valley, Cruz hopes the community will make a notable contribution to the research.
“I think that’s something that I think the community needs to be aware of — that impact that they will have on the Hispanic community of MS patients,” Cruz said. “If they decide to participate, they will be making a difference.”
Locally, recruitment for the trial began about three weeks ago, though other sites have been recruiting for a lot longer.
The double-blind study will last two and a half years though there will be an extension study that will last up to five years after that. Those who participate in the extension study will all receive the new medication.
“If we are able to get enough participants, this might be the first medication of which we do have specific data regarding Hispanics in response to this medication in MS Hispanics,” he said, “which I think is going to be huge.”
