INmune Bio Receives FDA Fast Track Designation for XPro1595 in Early Alzheimer's Disease

INmune Bio announced that the FDA has granted Fast Track designation to XPro (pegipanermin), a first-in-class selective soluble TNF inhibitor, for treating early Alzheimer's disease including mild cognitive impairment and mild dementia. The designation facilitates expedited development and review, recognizing the urgent need for treatments addressing neuroinflammation in Alzheimer's. The company plans to execute a Phase 2b/3 precision-medicine registrational program targeting patients with biomarkers of inflammation.