INmune Bio, Inc. (NASDAQ: INMB) has announced the completion of patient enrollment in its Phase 2 clinical trial (AD02) for early Alzheimer's disease. The global, blinded, randomized trial reached a total of 208 patients, exceeding initial targets. This study is focused on individuals exhibiting biomarkers indicative of elevated neuroinflammation, a key factor in the progression of Alzheimer's disease. Top-line cognitive results are anticipated in the second quarter of 2025.
Targeting Neuroinflammation in Early Alzheimer's
The Phase 2 trial is employing XPro™, a novel therapeutic agent designed to target glial cells, which are instrumental in driving neuroinflammation within the brain. By selectively neutralizing soluble TNF, XPro™ aims to mitigate neurodegeneration and demyelination, while simultaneously enhancing synaptic function and promoting remyelination. This approach is based on the increasing recognition of neuroinflammation as a critical contributor to the development and progression of neurodegenerative diseases, including Alzheimer's.
Trial Design and Patient Population
The AD02 trial is a global, blinded, randomized Phase II study. The trial enriches the patient population selecting for Early AD patients with evidence of neuroinflammation as a primary cause of their cognitive decline. Of the 208 patients enrolled, 56% presented with mild Alzheimer's disease, and 44% were diagnosed with mild cognitive impairment (MCI). The primary endpoint of the trial is the change from baseline in cognitive function after 24 weeks of treatment, as measured by the EMACC (Early and Mid-stage Alzheimer's Cognitive Composite) and CDR-SB (Clinical Dementia Rating-Sum of Boxes) scales.
Management Commentary
"We are excited to have completed administering first doses to all patients enrolled in our phase 2 Alzheimer’s trial," stated RJ Tesi PhD, the CEO of INmune Bio. "A global trial of this size is a major accomplishment for INmune and is a testament to the hard work and dedication of our team. The trial ended up overenrolled with a total of 208 patients, 56% of whom were categorized as mild AD and 44% as MCI. We look forward to releasing top line cognitive results in the second quarter of 2025."
The Role of Neuroinflammation in Alzheimer's Disease
Neuroinflammation, characterized as chronic inflammation within the brain, is increasingly recognized as a significant factor in the pathogenesis of neurodegenerative conditions, including Alzheimer's disease. This chronic inflammation contributes to nerve cell death and synaptic dysfunction, ultimately leading to cognitive decline. INmune Bio's XPro™ is designed to counteract these effects by blocking neuroinflammation, decreasing neurodegeneration, improving synaptic function, and promoting remyelination.
