Evobrutinib is the first BTK inhibitor to be evaluated for the treatment of MS, although other drugs in the class have been used to treat certain forms of cancer. It’s currently undergoing clinical trials for safety and efficacy, and new results from a phase 2 study were presented on April 18 during the 2021 annual meeting of the American Academy of Neurology (AAN). Earlier results of the study were published in 2019 in the New England Journal of Medicine.
Evobrutinib Reduced a Key Biomarker of Nerve Cell Damage and Inflammation
In this newer analysis of the phase 2 trial data, evobrutinib was found to significantly reduce blood neurofilament light chain levels, a key biomarker of nerve cell damage and inflammation in people with RMS, when compared with a placebo. A biomarker is a measurable substance whose presence is indicative of disease, and high levels of neurofilament light chain, a type of protein, in the blood is considered a sign of the nerve cell damage that causes MS and the brain atrophy, or loss of brain volume, that occurs with the disease, according to a study coauthor, Jens Kuhle, MD, PhD, the head of the multiple sclerosis center at the University Hospital Basel in Switzerland. “The data presented at AAN provide key insights into the role evobrutinib may play in modulating the clinical course of MS and further suggest that BTK inhibition with evobrutinib may reduce tissue damage associated with MS,” Dr. Kuhle notes. “The findings from this analysis are encouraging and show a strong potential for evobrutinib in the treatment of people living with MS.”
BTK Inhibitors Could Short-Circuit Autoimmune Attack in MS
As the name suggests, the BTK inhibitors are designed to limit production of Bruton’s tyrosine kinase in the body. BTK plays a role in the development of B cells, a type of white blood cell involved in the human immune system. MS is an autoimmune disorder, or one in which the immune system attacks healthy tissues in error, and it’s thought that this new class of drugs could short-circuit this process.
Phase 3 Trials Currently Enrolling Participants
Kuhle and his colleagues evaluated the effects of evobrutinib in 166 people with RMS, at a twice-daily dose of 75 milligrams. Those treated with the drug had, on average, about 19 percent lower levels of neurofilament light chain in the blood after 12 weeks and 17 percent lower levels after 24 weeks. This same dose is being used in two phase 3 trials of the drug — nicknamed evolutionRMS 1 and evolutionRMS 2 — which are currently enrolling participants. (Drugs must pass through a minimum of three trial phases before they can be approved for use.) In these studies, the safety and efficacy of evobrutinib will be compared with that of Aubagio (teriflunomide). As encouraging as the study results are so far, “Treating MS patients with BTK inhibitors is currently being studied and, so far, [none of these drugs] have been approved for the treatment of [the condition],” Kuhle cautions.
