US EditionAlzheimer's Setback Hits INmune Bio Stock, But FDA Hopes Remain - INmune Bio (NASDAQ:INMB)
- INmune Bio's Phase II MINDFuL trial of the TNF inhibitor XPro in early Alzheimer's disease concluded after the FDA lifted a clinical hold in January 2024.
- The clinical trial was placed on hold by the FDA starting in May 2022 because of issues related to manufacturing, and although the study did not achieve its main cognitive outcome in the overall intent-to-treat population, early positive signals were observed in a biomarker-selected subgroup.
- Findings indicated a 0.27 effect size improvement on the primary cognitive measure for early Alzheimer's disease, along with decreased blood pTau217 levels in patients exhibiting two or more inflammatory biomarkers, without any observed safety issues such as ARIA-E.
- CEO Raymond Tesi expressed that the findings demonstrate promising prospects for XPro, indicating it could provide benefits to Alzheimer's patients regardless of age, comorbidities, or ApoE4 status, even as the company’s shares fell by more than 56% amid investor doubts.
- INmune Bio plans a Q4 2025 meeting with the FDA to discuss a pivotal trial and intends to file for Breakthrough Therapy Designation, with additional data to be presented at the AAIC in July 2025.
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