INmune Bio, Inc. announced it has received European Medicines Agency's (EMA) Authorized Decision from the Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) in France and the Agence Espanola de Medicamentos y Productos Sanitarios (AEMPS) in Spain to initiate a Phase II trial in Early Alzheimer's Disease (AD) with XPro. This authorization follows the acceptance of the Company's Clinical Trial Application (CTA) under EU Clinical Trials Regulation and prior EMA's Authorized Decision in Poland on Nov. 15, 2023.

The Spanish and French arms are part of the Company's international clinical development strategy for XPro?? in patients with early AD. The Phase II clinical trial is a global, multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation.

In a prior Phase I open-label trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro demonstrated notable decreases in neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a "virtual biopsy" of the brain, treatment with XPro??

demonstrated improvements in the structural integrity of both gray and white matter in the brain. XPro(XPro1595, pegipanermin) is a next-generation selective inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF or TNF receptors. XPro could potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, decreasing neurodegeneration while improving synaptic function and promoting remyelination.

For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio's website.