INmune Bio Alzheimer’s Drug Misses Trial Goals, Stock Plummets

INmune Bio’s stock dropped over 50% after its Phase II MINDFuL trial showed no significant benefit from XPro (pegipanermin), a selective TNF inhibitor, in early Alzheimer’s patients. While the overall intent-to-treat population saw no improvement at six months, a subgroup with two or more inflammatory biomarkers showed modest gains in cognitive scores and reduced pTau217 levels, suggesting potential benefit.

XPro was well tolerated, with no cases of ARIA-E or ARIA-H, though injection site reactions led to ten discontinuations. INmune Bio plans to seek FDA breakthrough designation and engage regulators for a pivotal trial. More data will be shared at the Alzheimer’s Association International Conference in July.

The trial concluded a year after resolving an FDA clinical hold. The Alzheimer’s treatment space remains competitive, with only a few approved therapies like Leqembi and Kisunla facing regulatory and reimbursement hurdles globally.

01-07-2025