INmune Bio Inc. (NASDAQ: INMB) stock gained by at last close whereas the INMB stock-price declines by in the after-hours trading session. INmune Bio is a publicly-traded clinical-stage biotechnology firm dedicated to creating disease-fighting therapies that target the innate immune system.
INMB stock’ Recent Development
INmune Bio confirmed that XPro (pegipanermin) which is the company’s specific DN-TNF inhibitor candidate for the therapy of Alzheimer’s disease, treatment-resistant depression, and other neurological diseases in which neuroinflammation is implicated, was found to reduce multiple species of Phospho Tau (pTau) and enhance neuroimaging biomarkers of myelination in Alzheimer’s disease patients.
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These biomarker results come from the Company’s recently completed Phase 1 XPro research in Alzheimer’s patients. Patients with Alzheimer’s disease who received 1.0 mg/kg of XPro once a week for three months saw a 46 percent decrease in CSF pT217 (p0.0001) and a smaller decrease in pT181 (p0.01). While pT181 is the most widely used CSF biomarker for Alzheimer’s disease, recent research suggests that pT217 has a higher discriminative accuracy for the disease and a stronger association with amyloidosis and cognitive deterioration.
In addition, the company observed improvements in white matter MRI parameters, including a 16 percent increase in radial diffusivity, a remyelination indicator. These findings support prior findings of increased apparent fiber density (axonal integrity) and free water (neuroinflammation). All across the 12-month extension experiment, improvements were seen in each parameter.
By the end of 2021, the company hopes to begin enrolling patients in a blinded, randomized Phase 2 trial in people with moderate Alzheimer’s disease. A total of 200 patients will be enrolled in the six-month trial, which will take place in locations across North America and Australia. Patients will be given 1mg/kg of XProTM by subcutaneous injection once a week. EMACC Early AD/Mild Cognitive Impairment Alzheimer’s Cognitive Composite (EMACC), a sensitive assessment of cognitive function, is the major endpoint.
RJ Tesi, CEO of INmune Bio commented,
The results of this Phase I trial reveal that XPro reduces neuroinflammation and nerve cell death while improves neurorepair biomarkers in patients with Alzheimer’s disease. Modifications in neuroimaging biomarkers of remyelination can now be added to the positive benefits of XProTM in these individuals. They expect to show that when XProTM reduces neuroinflammation and neurodegeneration, enhances axonal quality, and stimulates remyelination, there is a quantifiable improvement in the patient’s cognitive function in their next Phase 2 trial.