Edison

Edison’s clinical development strategy is based on the use of human biomarkers that reflect cellular energy function to assess drug action. Today, clinical trials in many diseases, such as neurodegenerative disease can be long, and involve large numbers of subjects. In addition selection of proper drug dose for human investigation is complicated by the frequent absence of animal models predictive of human disease. The inability to accurately select dose and conduct expedited trials on small numbers of patients increases the cost and risk of clinical development– especially for first in class drugs. Edison has addressed this issue by the development of a clinical biomarker test – the Mitochondrial Stress Test™.

The MST™ is analogous to a traditional cardiac stress test, which uses exercise to evaluate heart performance under increasing workloads. The MST™ uses exercise to exaggerate defects in metabolic pathways, making their identification and characterization more readily identifiable. Patients are subjected to increased effort on a stationary bike, and their blood and exhaled air sampled at predetermined work intervals. The analysis of standard analytes yields physiologic indices of energy metabolism that include oxygen consumption, and lactate production– both specific but coarse indices of energy defects. To obtain higher resolution indices of metabolic pathways associated with energy defects, Edison is conducting an analysis of over 1,000 blood metabolites and using this data to not only discern whether these is an energy defect, but the type and precise location. The company believes this higher resolution metabolic map will expedite clinical trials through improving the ability to measure drug action prior to clinical improvement, thereby insuring proper dose selection before conducting lengthy trials at potentially the incorrect dose. In addition, the grouping of individuals with the same genetic and metabolic defects will reduce the number of subjects required in a study to observe drug response. Currently, Edison alone and with corporate and foundation partners is implementing the MST™ in 4 disease areas.