Studies funded under the 2012 TDI award revealed that peripheral administration of XPro1595 in the 6-OHDA (neurotoxin) pre-clinical model afforded significant neuroprotection against loss of dopamine neurons and motor deficits when dosed three days following experimental procedures (Barnum et al., Journal of Parkinson's Disease, 2014). These promising results provide compelling rationale to advance XPro1595 to a pre-clinical model that represents the human disease in which we can evaluate the therapeutic efficacy of XPro1595 on motor and non-motor outcome measures that will directly inform design of a clinical trial of XPro1595 in Parkinson's disease (PD).
We will evaluate the therapeutic effect of systemic XPro1595 in a pre-clinical model using motor and non-motor outcome measures that will directly inform on the design of a clinical trial with XPro1595 in Parkinson's.
We will assess the extent to which systemic XPro1595 administration reduces neuroinflammation (brain microglia, type of brain cell) activation and fluid inflammatory biomarkers in plasma and cerebrospinal fluid (baths the brain and spinal cord; CSF)), dopaminergic deficits, gut dysfunction and cognitive behavior in a pre-clinical model of parkinsonism when administered following experimental procedures.
Impact on Diagnosis/Treatment of Parkinson's Disease:
Successful results with systemic XPro1595 on inflammatory markers and non-motor outcome measures would support a path forward for a 60-day biomarker-directed trial in early stage PD.
Next Steps for Development:
FPRT Bio would be poised to seek investors and potential industry partners for a clinical trial in early stage PD.