Sécurité

INmune Bio Receives EMA’s Authorization in France and Spain for Phase II Clinical Trial of XPro™ for Early Alzheimer’s Disease

Retrieved on: 
Monday, November 27, 2023
Phase, Patient, Alzheimer's disease, MRI, Sécurité, EMA, White matter, Brain, Inflammation, Medication, ANSM, Authorization, Biomarker, CTA, AEMPS, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • 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.
  • 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.