INmune Bio’s unique Alzheimer’s trial endpoint gains validation

INmune Bio’s AD02 trial has successfully resumed following a previous FDA clinical hold, focusing on its primary endpoint, the Early Mild Alzheimer’s Cognitive Composite (EMACC). EMACC serves as an objective measure of cognitive function, crucial for detecting early-stage Alzheimer’s-related cognitive changes. It includes assessments like word list learning, category fluency, and digit symbol coding tests.

This trial marks the first use of EMACC as a primary endpoint, with interim analysis confirming its effectiveness as intended. INmune Bio engaged a third-party evaluation of interim data from six-month trial completers, leading to a blinded sample size adjustment that validated sufficient trial power.

Initially halted due to manufacturing issues in May 2022, the trial received FDA clearance in December 2023, following additional data requests on therapy potency. Subsequently, the clinical hold was lifted in January this year, boosting company shares by 2%.