Oxford Brain Diagnostics’ grey matter quality measure selected as secondary outcome for Alzheimer’s Phase 2 clinical trial

Approximately 201 patients will be enrolled to study the XPro™ intervention. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro™ in patients with mild AD.

Oxford, UK, 29th March 2022. Oxford Brain Diagnostics, a software company focused on developing diagnostics that identify changes in the brain at a cellular level, today announced that their Cortical Disarray Measurement (CDM®) has been appointed as a secondary outcome measure for a Randomized, PlaceboControlled, Double-Blind Study of XPro™ in Patients with Mild Alzheimer’s Disease with Biomarkers of Inflammation. The trial sponsor is INmune Bio, a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that harness the patient’s innate immune system to fight disease. The trial will use CDM® technology to assess the efficacy of XPro™ compared with placebo on grey matter integrity in patients with mild AD.

The role of the immune system and inflammation in Alzheimer’s disease has been broadly known for years but it is becoming increasingly clear that effective management of AD may require anti-inflammatory strategies.

Dr Steven Chance, CEO, Oxford Brain Diagnostics said ‘we are very proud to be partnering with INmune Bio on this phase 2 AD clinical trial using CDM® as a secondary outcome measure. Alzheimer’s remains a complex condition and our involvement in this trial means that monitoring the interaction between the cortical microstructure and neuroinflammation offers the potential for a new angle on our understanding of the disease. We believe that neuroimaging (especially diffusion MRI) has a transformative role to play in offering specific biomarkers to measure trial endpoints as a gold standard measure of neurodegeneration’.

We are big believers in the use of imaging biomarkers to help with staging and treatment of patients with dementia.” Dr RJ Tesi, CEO, INmuneBio said ”Cortical Disarray Measurement allows us to quantify the pathology in the grey matter of patients with AD and monitor their response to therapy with XPro. In the future, we hope this type of biomarker response will help predict a therapeutic benefit long before clinical benefits can be measured.”

Oxford Brain Diagnostics Ltd is rethinking how brain health is assessed and managed. Founded in neuropathological and neuroimaging expertise, the company’s patented Cortical Disarray Measurement (CDM®) technology uses MRI brain scan data to support early and differential diagnosis, track progression, and predict the decline of neurodegenerative diseases. Oxford Brain Diagnostics is committed to assessing brain health based on changes in the cellular structure, supporting drug development, and helping clinicians around the world in their fight to defeat Alzheimer’s and other neurodegenerative diseases.

INmune Bio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trials to determine if it can treat cancer (INB03™), Mild Alzheimer’s disease, Mild Cognitive Impairment and treatment resistant depression (XPro). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation.