Neurologic Disease Research and Drug Development

The incidence of neurologic disorders is increasing in industrialized countries. Alzheimer’s Disease is a chronic neurodegenerative progressive disease with unknown causes. The diagnosis is mainly based on clinical symptoms using medical imaging and biomarkers. Another devastating chronic neurologic disorder is Multiple Sclerosis (MS), which is characterized by a progressive demyelination of the CNS of autoimmune pathogenesis. Although it is known that a chronic autoimmune reaction causative of MS is mainly diagnosed by clinical signs and symptoms, imaging, and the measurement of biomarkers, the differentiation to other diseases is extremely challenging and the need for specific biomarkers to be analyzed in serum and CSF is immense. Examples of CNS-specific biomarkers include αβ42 and total Tau, neurofilaments light chain and osteopontin.

The treatment of neurologic disorders is extremely challenging as their causes are often not yet fully understood. Based on data that there is an autoimmune component involved in the development of MS, monoclonal therapeutic antibodies such as natalizumab (against alpha4 integrin), rituximab/ofatumumab (against CD20), or alemtuzumab (against CD52) are approved as single or combined administration for its treatment. There is also promise in drug candidates that treat a possible viral cause of MS, as published recently with the bioanalytical work from the BioAgilytix team (Curtin F, Vidal V, Bernard C, Kromminga A, Lang AB, Porchet H. MAbs. 2016;8(5):854-60). This scientific publication demonstrates that pharmaceutical and biotechnology companies involved in neurologic disease-related drug development will need a CRO partner prepared for the complexities these neurology biologics pose in any phase of development.