The senior investigator at the National Institutes of Neurological Disorders and Stroke outlined studies on anakinra and tolebrutinib as part of a new phase 2a clinical trial paradigm.
“We really have 2 goals here. One is obviously to try to treat this chronic inflammation and promote lesion repair. But, secondly, it's to use these trials to understand the biology so that the next trial we do, [either] the third one or a trial somebody else does, will be better and more focused with better outcome measures.”
Two open-label studies are underway to evaluate the effects of anakinra (NCT04025554) and tolebrutinib on 7-Tesla magnetic resonance imaging paramagnetic rim lesions in multiple sclerosis.1 These studies, part of a new phase 2a clinical trial paradigm, were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 25-27, by Jemima Akinsanya, DO, Neuroimmunology Clinical Fellow, National Institutes of Health (NIH).
Approved by the FDA for the treatment of rheumatoid arthritis and neonatal-onset multisystem inflammatory disease in 2001, anakinra is a recombinant human interleukin-1 receptor antagonist.2 Tolebrutinib is an investigational, orally available, brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor.
NeurologyLive spoke with a principal investigator of the study, Daniel Reich, MD, PhD, senior investigator, National Institutes of Neurological Disorders and Stroke, NIH, to learn more about the potential of anakinra and tolebrutinib in treating chronic inflammation in MS. He additionally outlined the details of the 2 studies that make up the new paradigm.
For more coverage of ACTRIMS Forum 2021, click here.