BioVie Inc (NASDAQ:BIVI) announced that it has presented data showing its lead drug asset NE3107 may restore homeostasis via specific genes associated with dementia, metabolism and inflammation.
Additionally, the company said that bezisterim has been approved as the generic name for NE3107 by the United States Adopted Names Council and World Health Organization International Nonproprietary Names expert committee.
BioVie senior vice president, Alzheimer’s disease program Dr Christopher Reading presented the additional data for bezisterim at the 12th Annual Alzheimer’s & Parkinson’s Drug Development Summit held in Boston from April 23 to 25.
The data comes from additional analysis of the information generated during BioVie’s Phase 3 trial of bezisterim in patients with Alzheimer's disease that was unblinded at the end of 2023.
It showed that patients treated with bezisterim experienced an age deceleration advantage over patients treated with placebo on four “biological clocks,” which measure the extent of DNA methylation.
DNA methylation is a natural process where methyl groups are added to the surface of DNA and interfere with the body’s ability to decode genetic inflammation. It accumulates as people age and can be influenced by behavioural and environmental factors.
Hypermethylation of DNA is associated with many diseases, including dementia, Parkinson’s and various types of cancer.
The new data showed patients treated with BioVie's bezisterim saw a negative 4.77 year advantage on the Inflammation Age Clock, a negative five year advantage on the Hannum Age Clock, a negative 1.92 year advantage on the GrimAge Clock and a negative 3.71 year advantage on the PhenoAge Clock.
The company said bezisterim’s ability to reduce DNA methylation appears to target 21 specific genes identified to date.
It added that statistically significant correlations were found between DNA methylation levels for 15 genes and various clinical measures for bezisterim-treated patients but were not observed for placebo patients.
BioVie said this suggests that DNA methylation levels among placebo patients accumulated to such an extent that they disrupted the natural linkage between the gene and the clinical measure, and that bezisterim was able to restore such homeostatic relationships.
Placebo patients also saw a significantly significant correlation between DNA methylation levels for six pro-inflammatory genes and clinical measures, which BioVie said suggests that bezisterim disrupted the negative consequences of DNA methylation that promotes inflammation and restored homeostasis.
Cuong Do, BioVie CEO, said the data is evidence that bezisterim could help people stay healthier for a longer time as they age.
“BioVie believes that DNA methylation may not need to constantly increase as we age, and thus the progression of age-related disease may not be uni-directional,” Do said.
“Bezisterim is believed to be the first drug candidate that has shown in clinical trials the ability to modulate the level of DNA methylation, and do so in a manner that’s correlated with disease. But we are only at the beginnings of exploring the full potential of this unique molecule and how it can help modulate the progression of age-related diseases.”