Researchers at the biotech Bionure –dedicated to the search of strategies to control multiple sclerosis, located at Barcelona Science Park– and in collaboration with the Hospital Clinic of Barcelona / Auguts Pi i Sunyer Biomedical Research Institute (IDIBAPS), have been successful in preventing and improving the course of multiple sclerosis in preclinical phase by preventing damage to nerve tissue. The studies led by Dr. Pablo Villoslada, a multiple sclerosis specialist at the Hospital Clinic -co-founder of Bionure and director of the Neuroimmunology group at IDIBAPS- have successfully identified 9 molecules with a neurotrophin type of activity that activate neuron signaling pathways, preventing cell death and exerting neuroprotective effects on brain inflammation and neurodegeneration models.

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These data, presented at the Congress of the American Academy of Neurology, endorse the idea of developing therapies with neuroprotective drugs that prevent and improve the course of diseases such as multiple sclerosis, although the aim is also include other pathologies such as Parkinson’s disease or glaucoma. In this regard, the European Union has just given its approval to the creation of the CombiMS European consortium to develop new paradigms for improving the process of drug discovery through systems biology.

Multiple sclerosis (MS) is an autoimmune disease that results from the attack of the immune system to the central nervous system (CNS), leading to the loss of myelin and axonal damage, causing long-term disability. The pathophysiology of multiple sclerosis is complex, involving genetic and environmental factors that define susceptibility to generate the autoimmune attack. In the last decade, several immunomodulatory drugs have been approved such as recombinant proteins, beta-interferon, monoclonal antibodies such as natalizumab, or chemical products, such as glatiramer acetate, or fingolimod. In addition, there is a range of new immunomodulators currently undergoing phase II or III studies.

However, currently there are no approved treatments that directly reduce the damage to the nervous system or improve their repair, which is a priority for patients with sequelae. New neuroprotective agents have been identified in preclinical studies but their development is still slow and difficult due to the absence of adequate and in-depth knowledge of the damage mechanisms to the CNS caused by inflammation, as well as the lack of clinical platforms to test their effectiveness.

Now a great opportunity opens up, as increasingly early diagnosis of the disease can be established, allowing the initiation of prevention measures earlier. Moreover, technological improvements in diagnostic imaging have also improved greatly, allowing and facilitating the assessment of the advance made in these drugs. These advances, presented by Bionure in preclinical phase in vitro laboratory studies and in studies on laboratory animals are the result of this new vision of the disease and its treatment and give way to clinical trials in humans, which, provided everything goes well in the process, will start in summer 2013. The study design in humans will initially focus on the acute treatment of multiple sclerosis by the intravenous route. This will allow the research team to detect neuroprotective effects in acute stages of the disease. The following steps will focus on intervention in chronic phases of the disease and on other routes of administration such as the oral route.

Leading a new European project

The European Union has approved the creation of CombiMS, a European project to develop a new method based on systems biology to improve the drug discovery process. CombiMS has duration of two years and a budget allocation of € 3 million. Through the application of this new methodology, CombiMS aims to identify new combination therapies for the treatment of MS, as well as biomarkers to assess therapeutic response.

The consortium has 8 members, some of whom are academic partners –such as the members from the IDIBAPS-Hospital Clínic, University of Zurich (Switzerland), the Karolinska Institute (Sweden), the hospitals of the Charité (Germany), and ‘the European Bioinformatics Institute from the European Molecular Biology Laboratory (UK)– and other are business partners such as Anaxomics Biotech (Spain), Prot-At-Onze (Greece) and Bionure Farma, which is leading the project.

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