A new 48-week study of the investigational drug evobrutinib in patients with relapsing remitting MS (RRMS) showed it reduced the number of enhanced MRI lesions (T1 gadolinium-enhancing lesions) among those taking it.
The results of the new Phase II double-blind placebo controlled study were presented at the American Academy of Neurology (AAN) 2019 Annual Meeting in Philadelphia, USA, and published in the New England Journal of Medicine (NEJM).
Evobrutinib, which is given as a tablet, inhibits an enzyme called Bruton’s tyrosine kinase (BTK), reducing the activation of B cells and inhibiting immune cells called macrophages which have been linked to MS progression. By inhibiting this enzyme, it is believed evobrutinib reduces damage to nerve cells in MS.
The new 48 week trial builds on previously reported data about evobrutinib which showed the drug had an effect in reducing the number of T1 gadolinium-enhancing lesions over 12 weeks. The importance of the latest study is that it demonstrates this lesion reduction is sustained over a period four times as long as in the original trial. Importantly, no treatment associated infections or other side effects were seen and no new safety signals were identified over the longer 48 week trial period.
"Building on our initial analysis, these new data further demonstrate the potential role of evobrutinib in RRMS, subject to further clinical investigation" said Dr. Xavier Montalban, Professor of Medicine and Department Division Director, Neurology, at the University of Toronto and Director of the MS Centre at St. Michael's Hospital, Canada, and Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain.
"Evobrutinib is the first Bruton's tyrosine kinase inhibitor to demonstrate clinical proof of concept in multiple sclerosis. We are pleased that these 48-week data further support our continued clinical development of evobrutinib and investigation into its efficacy for patients with MS," he added.
Source: MS-UK 14/05/19