INmune Bio Inc. (NASDAQ: INMB) has announced the completion of enrollment for its Phase 2 clinical trial (AD02) evaluating XPro™ (pegipanermin) in patients with early Alzheimer's Disease (AD) and biomarkers of elevated neuroinflammation. The global, blinded, randomized trial reached its target enrollment on September 27, 2024.
Trial Design and Patient Population
The AD02 trial focuses on individuals with early AD, including those with mild cognitive impairment (MCI) and mild AD. Participants must exhibit at least one of four biomarkers indicative of inflammation: elevated C-reactive protein (CRP), glycated hemoglobin (HgbA1c), erythrocyte sedimentation rate (ESR), or the presence of the ApoE4 allele. Enrolled patients will receive either XPro™ or a placebo in a 2:1 ratio via once-weekly subcutaneous injections over a six-month period. Cognitive endpoints include the EMACC (presumably the Enhanced Multi-Attribute Cognitive Composite) and CDR (Clinical Dementia Rating) scales.
XPro™: Targeting Neuroinflammation in AD
XPro™ (pegipanermin) is a next-generation inhibitor of tumor necrosis factor (TNF), designed to selectively neutralize soluble TNF (sTNF) without affecting trans-membrane TNF (tmTNF) or TNF receptors. Neuroinflammation, a key contributor to neurodegenerative diseases like AD, involves chronic brain inflammation that can lead to nerve cell death and synaptic dysfunction. By inhibiting sTNF, XPro™ aims to reduce neuroinflammation, potentially improving cognitive function and neuronal communication.
Significance of the AD02 Trial
"This is a significant milestone for INmune Bio, its partners, and more importantly, for those who have participated in the study," said CJ Barnum PhD, VP of CNS Drug Development who leads the AD02 trial. Patient enrollment in excess of the 201-patient goal will improve the power of the trial and we greatly look forward to the final study results.
The completion of enrollment marks a crucial step in assessing the therapeutic potential of XPro™ in addressing the underlying neuroinflammatory mechanisms of Alzheimer's disease. The results of the AD02 trial are eagerly anticipated, as they could provide valuable insights into a novel approach for treating early AD by targeting neuroinflammation.
