An international team of scientists led by Ludwig Kappos, from the University Hospital of Basel, and whose principal investigators include Xavier Montalban, head of the Clinical Neuroimmunology Unit of the Vall d'Hebron University Hospital, has demonstrated for the first time the effectiveness in humans of an oral drug for the treatment of multiple sclerosis in flares. The study, which included patients from 32 centers in 10 European countries and Canada, is published in today's edition of the prestigious scientific journal The New England Journal of Medicine.

The study has made an initial finding of the effects in humans of fingolimod, a new oral immunomodulatory agent developed by Novartis Laboratories, which in animals has been able to prevent the onset of the disease and reduce the neurological deficits caused by it. The drug acts by slowing down the immune system's attacks on the nervous system.

The human study, which initially involved 281 patients, consisted of a first six-month phase - completed by 255 patients - in which one group took fingolimod and another group took a placebo. Subsequently, in a second phase, also lasting six months and completed by 227 patients, the patients who had taken the placebo also received the new drug.

During the first phase, it was demonstrated that fingolimod significantly reduced both the number of brain lesions detected by magnetic resonance imaging and the clinical activity of the disease. During the second phase, an improvement was detected in patients who switched from placebo to drug. These encouraging results have meant the immediate launch of studies with more and longer patients which, if positive results are obtained, could lead to the authorization and commercialization of the new drug.

Multiple sclerosis is a disease in which, for unknown reasons, the individual's immune system attacks the nervous system itself and causes the progressive destruction of myelin, a substance that envelops nerve cells. It is the most common non-traumatic cause of neurological disability among young people between 20 and 40 years of age and has a prevalence of 60 out of every 100,000 inhabitants at home. It typically manifests in irregular outbreaks that can cause a wide range of symptoms, from visual problems to muscle weakness, coordination and speech difficulties, severe fatigue or pain.

The two main treatments currently available, beta-interferon and glatiramer acetate, are able to reduce flares by 30%. However, they are not always effective and, as they are administered by injection, they cause irritation and adverse reactions that can affect the quality of life of the patient.

The development of a new oral drug could increase the effectiveness of the existing set of treatments and reduce the inconvenience of injections. However, the study has also detected adverse effects of fingolimod, such as nasopharyngitis, shortness of breath, headache, diarrhea and nausea. Further studies with more patients and of longer duration will be decisive in determining the benefits and drawbacks of the drug.