Study Rationale: Parkinson’s disease (PD) is characterized by neuroinflammation and the loss of dopamine neurons. Recently, epoxy-fatty acids have been shown to be neuroprotective in preclinical models of PD. However, the clinical utility of these compounds is limited by their rapid metabolism by an enzyme called soluble epoxide hydrolase (sEH). Inhibiting sEH with a novel molecule called EC5026 has demonstrated potent neuroprotective properties in preclinical models of PD and other neurodegenerative conditions. should therefore reduce the inflammatory responses in PD. This study will test the safety and efficacy of EC5026 in people with PD.
Hypothesis: We hypothesize that the sEH inhibitor EC5026 will block deleterious neuroinflammation and other molecular responses that play key roles in the pathogenesis of PD.
Study Design: We will execute the study using two cohorts. In the first cohort, we will determine how well EC5026 penetrates the blood-brain barrier in people with PD. This data will provide crucial insights into the molecule’s central nervous system distribution and safety profile. In the second cohort, we will evaluate the safety and efficacy of EC5026 in 36 people with early to mid-stage PD in a Phase 1b clinical trial: 18 will receive EC5026 and 18 will receive a placebo. This study will assess the safety, tolerability and efficacy of EC5026 administered at two doses escalated over a 28-day treatment period.
Impact on Diagnosis/Treatment of Parkinson’s Disease: There are currently no therapeutics that can resolve PD pathologies and alter the course of PD progression. If successful, EC5026 could be used in conjunction with early biomarkers to prevent PD or stop or reverse the course of those currently with PD.
Next Steps for Development: Successful demonstration of safety and efficacy or pharmacodynamic changes that indicate a reduction of PD pathologies will justify initiating the larger efficacy studies required to advance EC5026 for approval to treat PD.
Trial Phase: Phase 1b/Phase 2