INmune Bio Phase 2 MINDFuL trial misses primary endpoint; positive subgroup data in inflammation-biomarker AD patients

Inmune Bio, Inc.

Primary cognitive endpoint EMACC not met in mITT (n=200); predefined subgroup with ≥2 inflammation biomarkers (n=100) showed cognitive benefit (effect size 0.27).
In same subgroup, behavioral benefit on NPI (effect size -0.24) and biological benefit on pTau217 (effect size -0.20).
XPro well-tolerated; no ARIA-E or ARIA-H; injection site reactions common (80% XPro vs <20% placebo).
Company to file for Breakthrough Therapy designation; End-of-Phase 2 meeting with FDA scheduled for Q4 2025.
Additional MINDFuL analyses to be presented at AAIC in Toronto, July 27-31, 2025.

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