INmune Bio, Inc. (NASDAQ: INMB) has announced the completion of patient enrollment in its Phase 2 clinical trial (AD02) for early Alzheimer's disease (AD). The global, blinded, randomized trial focuses on patients with biomarkers indicative of elevated neuroinflammation, a key factor in the progression of AD. The trial reached a total of 208 patients, surpassing initial expectations.
The AD02 trial is evaluating XPro™, a dominant-negative TNF inhibitor, in patients with early AD. XPro™ selectively neutralizes soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. The drug targets glial cells, aiming to decrease neurodegeneration and demyelination while improving synaptic function and remyelination. The primary endpoint of the trial is the change from baseline in cognitive function after 24 weeks of treatment, measured by the EMACC (Executive Memory and Attention Composite) and CDR-SB (Clinical Dementia Rating-Sum of Boxes) scales.
Targeting Neuroinflammation in Alzheimer's Disease
Neuroinflammation, a chronic inflammatory response in the brain, is increasingly recognized as a significant contributor to neurodegenerative diseases like Alzheimer's. It is characterized by the activation of glial cells and the release of pro-inflammatory cytokines, leading to nerve cell death and synaptic dysfunction. By targeting neuroinflammation, XPro™ aims to address a critical underlying mechanism of cognitive decline in AD.
RJ Tesi PhD, the CEO of INmune Bio, stated, "We are excited to have completed administering first doses to all patients enrolled in our phase 2 Alzheimer’s trial. 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."
Trial Design and Patient Population
The Phase 2 AD02 trial is a global, blinded, randomized study. Of the 208 patients enrolled, 56% were categorized as having mild AD, while 44% had mild cognitive impairment (MCI). The trial employs enrichment criteria to focus on patients with neuroinflammation as a primary cause of their cognitive decline. This targeted approach aims to enhance the likelihood of observing a treatment effect.
Current Alzheimer's Treatment Landscape
While current treatments for Alzheimer's disease primarily focus on symptomatic relief, there remains a significant unmet need for therapies that address the underlying disease mechanisms. Recent advances in understanding the role of neuroinflammation have opened new avenues for therapeutic intervention. XPro™ represents a novel approach by specifically targeting the inflammatory processes that contribute to neurodegeneration.
Anticipated Results
INmune Bio anticipates releasing top-line cognitive results from the AD02 trial in the second quarter of 2025. These results will provide valuable insights into the potential of XPro™ as a disease-modifying therapy for early Alzheimer's disease. The company's focus on targeting neuroinflammation could represent a significant advancement in the treatment of this debilitating condition.
