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In a Phase Ib trial, XPro1595 decreased biomarkers of neuroinflammation in patients with Alzheimer's disease (AD), significantly improving neurodegeneration and synaptic function. XPro1595 is an investigational protein that neutralises soluble tumour necrosis factor (TNF), a pro-inflammatory cytokine.
The goal of the ongoing open-label, dose escalation study is to demonstrate that XPro1595, when given as a subcutaneous injection once weekly, will decrease neuroinflammation in patients with mild to moderate AD.
The new data shows that after 12 weeks of therapy, patients had statistically significant reductions in the inflammatory cytokine/chemokine levels in their cerebrospinal fluid (CSF).
A proteomic analysis of CSF also revealed that treatment with XPro1595 led to a significant change in multiple AD-related pathways including immune/inflammatory response, central nervous system (CNS) neuronal function and injury, dendritic spine morphogenesis and synaptic plasticity.
"Demonstrating changes in neuroinflammatory biomarkers across multiple measures (CSF and MRI) and assays in a small dataset gives us great confidence that XPro1595 is having the desired effect in the [central nervous system] CNS," said Dr
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In the trial, the investigators are using novel neuroimaging techniques and validating new biomarkers to help predict which patients may respond to treating neuroinflammation and further understand the consequences of neuroinflammation in patients with AD. One biomarker validated by this study was magnetic resonance imaging (MRI) white matter free water as an indicator of neuroinflammation, which the researchers said could be used to measure treatment response in future studies.
About XPro1595
XPro1595 is a next-generation inhibitor of TNF with a unique mechanism of action - neutralising soluble TNF without affecting trans-membrane TNF or TNF receptors. By decreasing neuroinflammation, it could substantially benefit patients with AD, potentially improving cognitive function and restoring neuronal connections.
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