USFDAMay 14, 2026, 04:13 PM
INmune Bio XPro™ Gets FDA Fast Track for Early Alzheimer's Disease
AI Summary
INmune Bio Inc. announced that the FDA granted Fast Track designation to XPro™ (pegipanermin), its selective soluble TNF inhibitor, for the treatment of early Alzheimer's disease. This designation covers both mild cognitive impairment due to AD and mild Alzheimer’s disease dementia, recognizing the urgent need for treatments targeting neuroinflammation. The Fast Track status will facilitate development and expedite the review process for XPro™, which aims to alter the trajectory of this devastating disease.
Key Highlights
- FDA granted Fast Track designation to XPro™ (pegipanermin) for early Alzheimer's disease.
- Designation covers mild cognitive impairment (MCI) due to AD and mild Alzheimer’s disease dementia.
- XPro™ is a first-in-class selective soluble TNF inhibitor targeting neuroinflammation.
- Fast Track facilitates development and expedites review for serious conditions with unmet medical needs.
- Allows more frequent FDA interactions and potential for expedited review mechanisms.
- Neuroinflammation is recognized as an independent, early driver of cognitive decline in AD.
- The Phase 2b/3 registrational program will enroll patients with biomarkers of inflammation.
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