Study Rationale: According to The Michael J. Fox Foundation, the need for biomarkers that provide an objective assessment for Parkinson’s disease (PD) “has become more urgent as more projects enter human testing.” Such biomarkers would speed drug development by identifying people most likely to respond to treatment, monitoring disease progression and assessing drug efficacy. Octave has developed a precision-care platform for multiple sclerosis that includes a custom biomarker assay panel, now used in ~40 clinics in the U.S. Now, we will apply a similar approach and technology to develop a precision-care solution for PD, beginning with the establishment of a biomarker panel.
Hypothesis: We hypothesize that we can develop a customized test panel that fully represents the complexity and heterogeneity of PD, which will support earlier diagnosis, improved care and a means of measuring disease progression.
Study Design: Octave has developed a custom assay panel for multiple sclerosis called the MS Disease Activity test. In this study, we will use a similar process to take a custom assay panel for PD from feasibility and discovery through development and validation. This process will consist of conducting a broad series of studies with thoroughly characterized biospecimens, and identifying the most relevant proteins for PD assessments by correlating biomarker signatures with relevant endpoints and employing a systems biology approach to corroborating pathophysiology.
Impact on Diagnosis/Treatment of Parkinson’s disease: Our panel of fluid biomarkers will support a variety of clinical applications including earlier diagnosis, evaluation of drug therapies and monitoring of disease progression. Development of objective assessments will facilitate a deeper understanding of PD phenotypes and disease stages, enabling clinicians to better care for people with PD.
Next Steps for Development: After analytical and clinical validation, we will launch a pilot study with a selected clinic prior to pursuing a large-scale commercial launch. We understand that a continuum of studies will be necessary to build the body of evidence that expands claims and reinforces clinical utility.