USFDAMay 14, 2026, 08:02 AM
INmune Bio's XPro Receives FDA Fast Track for Early Alzheimer's
AI Summary
INmune Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to XPro (pegipanermin) for the treatment of early Alzheimer's disease. This designation covers both mild cognitive impairment due to AD and mild Alzheimer dementia, addressing a significant unmet medical need. The company believes XPro has the potential to alter the disease's trajectory by targeting underlying neuroinflammation, and the designation will facilitate development and expedite regulatory review.
Key Highlights
- INmune Bio's XPro (pegipanermin) received FDA Fast Track designation for early Alzheimer's disease.
- The designation covers mild cognitive impairment (MCI) due to AD and mild Alzheimer dementia.
- XPro is a first-in-class selective soluble TNF inhibitor targeting neuroinflammation.
- Fast Track designation facilitates development and expedites review for serious conditions with unmet medical needs.
- The designation provides opportunities for more frequent FDA interactions and potential eligibility for Rolling Review.
- XPro is designed to treat inflammatory biology driving disease progression in a subset of AD patients.
- The company plans a Phase 2b/3 seamless adaptive trial for XPro in patients with early AD and inflammation biomarkers.
- Alzheimer's Association estimates 7.4 million Americans age 65+ live with AD dementia, with 15 million experiencing MCI.