INmune Bio Inc. (NASDAQ: INMB) has announced the completion of patient randomization for its Phase 2 AD02 trial, a global study focused on early Alzheimer's disease (AD) patients exhibiting biomarkers of elevated neuroinflammation. The trial, which concluded enrollment on November 11th, includes a total of 208 patients.
Trial Design and Patient Population
The AD02 trial is a blinded, randomized Phase 2 study evaluating XPro™ in patients with early AD. The study enriches the patient population by focusing on individuals where neuroinflammation is believed to be a significant driver of cognitive decline. Of the 208 patients enrolled, 56% are categorized as having mild AD, while 44% have mild cognitive impairment (MCI).
Mechanism of Action and Therapeutic Target
XPro™ is designed to target glial cells, which are key mediators of neuroinflammation in the brain. By modulating glial cell activity, XPro™ aims to reduce neurodegeneration and demyelination, thereby improving synaptic function and promoting remyelination. This approach is based on the increasing recognition of neuroinflammation as a critical factor in the development and progression of neurodegenerative diseases, including Alzheimer's.
Endpoints and Anticipated Outcomes
The primary endpoint of the AD02 trial is the change from baseline in cognitive function after 24 weeks of treatment. Cognitive function will be assessed using the EMACC (Executive, Memory, Attention, and Cognitive Composite) and CDR-SB (Clinical Dementia Rating-Sum of Boxes) scales. Topline cognitive results from the trial are anticipated to be released in the second quarter of 2025.
The Role of Neuroinflammation in Alzheimer's Disease
Neuroinflammation, a chronic inflammatory process in the brain, is increasingly recognized as a significant contributor to the pathogenesis of Alzheimer's disease. It involves the activation of glial cells and the release of pro-inflammatory mediators, leading to nerve cell death and synaptic dysfunction, ultimately resulting in cognitive decline. Targeting neuroinflammation represents a promising therapeutic strategy for slowing or preventing the progression of Alzheimer's disease.
Company Statement
"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... We look forward to releasing top line cognitive results in the second quarter of 2025."
