BioVie announced data from a poster detailing the epigenetic basis for how in a Phase 2 exploratory biomarker study its drug candidate NE3107 may have potentially regulated specific genes in a manner significantly correlated with observed cognitive and biomarker improvements. The poster was presented yesterday at the Alzheimer’s Associate’s International Conference, AAIC, held in Amsterdam July 16-20, 2023. In the poster presentation, titled Treatment-Induced Epigenetic Modifications in MCI and Probable Alzheimer’s, presenters showed how patients with clinical dementia treated with NE3107 for 3 months saw greater than50% reductions in the level of DNA methylation of over 400 CpGs, and that some of these reductions were significantly correlated with observed improvements in various cognitive measures and biomarkers, as described below. 1) 14 CpGs related to anti-inflammatory genes that are significantly correlated with reduction in plasma TNFalpha levels, which is considered to the master regulator of inflammation. 2) 43 CpGs related to antioxidant genes which are significantly correlated with increases in precuneus glutathione levels from magnetic resonance spectroscopy of the brain. Decreased glutathione levels have been shown to be associated with cognitive decline. 3) Numerous CpGs associated with genes related to insulin signaling and antioxidant responses were significantly correlated with volumetric changes in the hippocampus, subcortical grey matter, as well as frontal, temporal, parietal, and occipital lobes. Volumetric changes in the brain have been associated with alterations in cognitive function in patients with MCI and dementia. 4) Numerous CpGs associated with insulin signaling, antioxidants, anti-inflammatory, anti-apoptotic, anti-amyloid, and neurostimulation were significantly correlated to improvements in cognition and traditional biomarkers of AD. In total, nearly 500 significant correlations were found between all the CpGs and cognitive assessments and over 300 significant correlations between CpGs and AD Biomarkers.
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