A phase II clinical trial led by Dr. Xavier Montalban, director of the https://www.cem-cat.org/ Center for Multiple Sclerosis of Catalonia (Cemcat), head of the Neurology / Neuroimmunology service of Vall d'Hebron and head of the research group in http://en.vhir.org/web_vhir/portal1/grup-equip.asp?s=recerca&contentid=186888&idrefer=186888 Clinical Neuroimmunology of the Vall d'Hebron Research Institute (VHIR), demonstrates that evobrutinib, the first inhibitor of Bruton tyrosine kinase (BTK) drug administered orally, substantially reduces active brain lesions in recurrent multiple sclerosis observed by magnetic resonance. The study, which was released today during the Annual Meeting of the American Academy of Neurology in Philadelphia (USA), the largest in the field of Neurology worldwide, has been carried out by the pharmaceutical company Merck and is published in the http://www.nejm.org/doi/full/10.1056/NEJMoa1901981 New England Journal of Medicine."Evobrutinib is the first administered orally, highly selective, Bruton tyrosine kinase inhibitor that demonstrates a proof of clinical concept in recurrent multiple sclerosis," says Dr. Montalban. "It is a very good chance for all people with recurrent multiple sclerosis that may opt for an oral treatment," he adds."This molecule is especially interesting from the therapeutic point of view because it has a dual mechanism that on the one hand inhibits the activity of B lymphocytes and on the other it affects innate immunity which means that it not only has an effect on the inflammation produced by the disease but also influences the progression of multiple sclerosis ", emphasizes the leader of the study.Phase II, multicenter double-blind and placebo-controlled study lasted 52 weeks. The efficacy and safety of evobruinitib was evaluated in patients aged 18-65 with recurrent multiple sclerosis (EMR), the form of the disease that has a course with relapses or outbreaks. The participants randomized themselves to several groups that received different doses of the drug, either dimethyl fumarate or placebo. 85 percent of the patients completed the entire 52 weeks of the study.The primary objective of the study was to achieve the reduction of brain lesions. To evaluate the condition of brain lesions, the magnetic resonance was used with a contrast agent, the gadolinium. The secondary objectives were the reduction of the rate of annualized relapses (average recurrence for one year) at week 48th and safety.Previously (October 2018) it had been announced that week 24th of the study had already reached the primary objective, reducing the number of brain lesions in patients with EMR compared to placebo. "With evobrutinib 75 mg at a daily dose and 75 mg two daily doses, a reduction in the number of lesions at week 12 of the treatment was observed. The current study shows that this reducing effect of injuries stays until week 48th, "explains Dr. Montalban. "Based on our initial analysis at week 24th, these new data further demonstrate the potential of evobrutinib for recurrent multiple sclerosis," he adds.With evobrutinib 75 mg BID (twice a day), 79 percent of patients didn't have any relapses during 48 weeks of treatment. "We are very pleased that these 48-week results further support our continued clinical development of evobrutinib and the investigation of its efficacy in patients with multiple sclerosis," he says. "The fact that the reduction is already observed at 12 weeks indicates that the drug begins to show positive effects quickly. This is especially relevant in the case of patients with outbreaks. "Regarding the adverse effects recorded, no infections associated with the treatment, lymphopenia or any other adverse effect that could compromise the safety of the drug during the 52 weeks of treatment were observed. The most frequent adverse effects were nasopharyngitis and the elevation of transaminases. These events started within 24 weeks after treatment began and disappeared when treatment was discontinued, with no clinical consequences within the 52-week study period.Multiple sclerosisMultiple sclerosis is an autoimmune disease in which the immune system attacks and damages the protective layer of neurons of the Central Nervous System. This coating is myelin, a biological membrane formed by proteins and fatty substances that allows the electrical conduction of the signals of the nervous system. It is the most disabling non-traumatic origin neurological disease among young adults. In fact, it is estimated that approximately 2.3 million people suffer from MS all over the world. Although the symptoms may vary from one person to another, the most frequent are blurred vision, numbness and tingling in the lower limbs, loss of strength and coordination problems. Without a treatment that definitely cuts the disease, there are currently more than 10 drugs that slow down and modify the course of the disease.