INmune receives EMA authorization in France, Spain for Phase II trial of XPro

INmune Bio 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 Agencia 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 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 trial is currently enrolling patients in Australia, Canada, and the United Kingdom. “The French and Spanish clinical sites will significantly broaden the trial in Europe. We are grateful for the collaboration from the ANSM and the AEMPS and look forward to continuing our progress toward completing enrollment of the Phase II trial. We believe clinical sites in these two countries will be significant contributors to the Phase II program and will be part of the global Phase III clinical trial,” said RJ Tesi M.D., CEO of INmune Bio.