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Patients with Alzheimer's Disease show improvement in brainwaves following 4 weeks of XPro™ therapy.
Boca Raton, Florida, March 05, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ:INMB) (the "Company"), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer's disease (AD) reports significant improvements in electroencephalography (EEG), a biomarker of brain function, in patients with moderate to severe Alzheimer's Disease treated with XPro™ for four weeks.
Patients who received weekly XPro™ treatment for four weeks had a statistically significant increase in Alpha wave frequency and power (p<0.05). Reduced Alpha power is linked with cognitive decline and the progression of Alzheimer's Disease. Alpha waves represent synchronized brain network activity that are essential for internal functions like mental arithmetic, short-term and working memory, and visual-spatial mental imagery exercises. In individuals with AD, Alpha wave power is diminished due to the breakdown of brain networks associated with degeneration.
"Functional benefits are the true benchmark of a drugs biological efficacy, and these promising findings are part of a larger narrative that's still unfolding," stated CJ Barnum, PhD, VP of Neuroscience at INmune Bio. "We are committed to extensive research, drawing from our Phase 2 placebo-controlled trial to substantiate these findings."
The seven patient pilot study in patients with moderate to severe AD sought to evaluate the utility of EEG as a functional biomarker of target engagement in evaluating the effects of XPro™ (XPro1595; pegipanermin), a next generation dominant-negative inhibitor of soluble TNF, in AD patients. These positive results support and add to the findings of the Phase 1 study in patients with AD that showed XPro™ treatment reduced biomarkers of inflammation and improved biomarkers of neurodegeneration, synaptic function and improved brain microstructure and promoted remyelination. The extent to which these biomarker changes impact cognition in patients with Early Alzheimer's Disease is currently being assessed in our ongoing randomized, placebo-controlled Phase 2 trial.
EEG, long considered a gold standard in objectively measuring brain activity, provides valuable insight into neural connectivity. Neurological research has consistently highlighted a progressive decline in alpha band power and frequency in individuals with MCI and Alzheimer's disease. EEG's capability to assess brain function makes these findings particularly noteworthy for INmune Bio's novel treatment strategy. The use of EEG as a biomarker for brain function and its potential as a regular measure in clinical trials was facilitated by Cumulus Neuroscience's innovative, FDA approved, portable EEG device.
"It is unprecedented to continuously monitor brain function at this scale. Our goal is to bring reliable, clinic-level brain function measurement into the comfort and familiarity of a patient's home," remarked Brian Murphy, Ph.D., Chief Scientific Officer of Cumulus Neuroscience. "The work highlights the untapped potential in utilizing task-synchronized EEG throughout the drug-development process in patients with Alzheimer's disease, which could revolutionize how clinical trials are conducted and treatments are evaluated."
Echoing this sentiment, Dr. Barnum emphasized, "Our work with Cumulus Neuroscience is forging new paths in Alzheimer's research, by empowering us with the ability to observe real-time effects of XPro™ on brain function directly within patients' everyday lives."
About EEG and Alpha Band Power in AD
EEG is the gold standard for measuring brain activity; informing on how well neurons are connected within the brain. Quantitative EEG is reported by the frequency and magnitude of the electrical signal. The frequency of the EEG is categorized by bands that correspond to distinct brain activities and states whereas the magnitude measures how active the neurons are within each band.
The alpha band power, defined around the 8 to 12 Hz frequency band, increases during internal tasks such as mental calculation, short-term and working memory or visual-spatial mental imagery exercises (Vaitl et al., 2005; Klimesch, Sauseng and Hanslmayr, 2007; Palva and Palva, 2007; Lutz, Dunne, and Davidson, 2012). It broadly reflects coordinated network activity in the brain and is expected to be reduced by the "disconnection" of networks seen in neurodegeneration.
In the context of natural aging, alpha power magnitude and frequency has been observed to reduce over the lifespan (Klimesch, 1999; Scally et al., 2018) and positively correlate with individual level of cognitive performance among a group of people of a similar age (Clark et al., 2004). In diseased populations, there is broad evidence connecting a fall in alpha power and frequency to cognitive decline and disease progression (Babiloni et al., 2020; Lejko et al., 2020). Reductions in alpha power and frequency are also associated with traumatic brain injury and have been observed to increase during recovery (Ianof and Anghinah, 2017; Conley et al., 2018). Specifically, global reduction in alpha power and frequencies are observed in MCI (Mild Cognitive Impairment) patients compared to healthy older adults, and progressive MCI is characterized by lower resting alpha power and frequencies compared to stable MCI (Lejko et al., 2020). Longitudinal studies in AD patients have also reported lower magnitude and frequency of alpha rhythms after yearly follow-up (Babiloni et al., 2020, 2024).
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