INmune Bio, Inc. (NASDAQ:INMB) (the, “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced that XPro™ (pegipanermin), the Company’s selective DN-TNF inhibitor candidate for the treatment of Alzheimer’s disease (AD), treatment resistant depression, and other neurological diseases where neuroinflammation is implicated, has been found to decrease multiple species of Phospho Tau (pTau) and improve neuroimaging biomarkers of myelination in patients with AD.
These biomarker data are from the analysis of the Company’s recently concluded Phase 1 study of XPro™ in Alzheimer’s patients. AD patients treated with 1.0 mg/kg of XPro™ once a week for three months had a 46% reduction is CSF pT217 (p<0.0001) and a lesser reduction in pT181 (p<0.01). While pT181 is recognized as the standard CSF biomarker of AD, recent studies suggest that pT217 has higher discriminative accuracy for AD and a stronger correlation with amyloidosis and cognitive decline.
“CSF pT217 appears to be the more sensitive tau biomarker of neurodegeneration in patients with AD, and our data show that controlling neuroinflammation decreases pT217,” said CJ Barnum, PhD, Head of Neurosciences for INmune Bio. “Tau pathology has been associated with decreased white matter integrity in AD and we believe these data are consistent with our biomarkers for the measurement of white matter pathology in patients with AD. White matter pathology starts early, the changes are measurable, and appear to be reversed following treatment with XProTM.”
The Company also reported improvement in white matter MRI metrics, including a 16% improvement in radial diffusivity, a biomarker of remyelination. These data add to previously reported improvements in apparent fiber density (axonal integrity), and free water (neuroinflammation). In each metric, improvements continued throughout the 12-month extension trial (the last time point assessed).
“The data from this Phase I trial show that XPro™ decreases biomarkers of neuroinflammation and nerve cell death while improving biomarkers of neurorepair in patients with AD,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “Now we can add improvements in neuroimaging biomarkers of remyelination to the beneficial effects of XProTM in these patients. In our upcoming Phase 2 trial, we hope to demonstrate that when XProTM decreases neuroinflammation and neurodegeneration, improves axonal quality and promotes remyelination, there will be a measurable benefit on the patient’s cognitive function.”
The Company plans to start enrolling a blinded, randomized Phase 2 trial in patients with mild AD by the end of 2021. The six-month trial will enroll 200 patients at centers across North America and Australia. Patients will receive 1mg/kg of XProTM weekly by subcutaneous injection. The primary endpoint is EMACC (Early AD/Mild Cognitive Impairment Alzheimer's Cognitive Composite), a sensitive measure of cognitive function.