BioVie reports results from bezisterim Phase 3 NM101 study

BioVie (BIVI) presented “Bezisterim Epigenetic Effects on Aging and Neurodegeneration” at the 7th World Aging and Rejuvenation Conference, or ARC-2025, taking place in Vienna, Austria, July 9th -10th.Unlike historical approach to Alzheimer’s Disease treatment that focuses on changing one gene product at a time, bezisterim modulates inflammation and is believed to help reestablish homeostasis and small changes in many genes at the same time. The data suggest that bezisterim may alter biological age by anti-inflammatory epigenetic modifications. Epigenetic biomarkers can measure “Epigenetic Age Acceleration”, which is defined as the difference between observed biological age as measured by DNA methylation and the chronological age. An analysis of the Company’s Phase 3 NM101 study evaluating bezisterim in patients with mild-to-moderate probable AD assessed 33 blood samples of patients treated with bezisterim and placebo using five validated epigenetic “biological” clocks that analyze genes linked to aging, as well as age-related inflammatory markers. In this analysis, treatment with bezisterim demonstrated After 30 weeks of treatment, the average difference between the placebo and bezisterim groups was -3.16 years for SBCAge, -4.12 years for PhenoAge, -1.38 years for GrimAge, -4.24 years for Hannum clock, and -3.77 years for InflammAge. The various “biological clocks” measure the extent of age deceleration1 advantage bezisterim-treated patients have compared to those treated with placebo. Bezisterim is a stabilized version of Beta AET, a naturally occurring brain metabolite of dehydroepiandrosterone, which has demonstrated anti-inflammatory and immunomodulating activity in humans, but that naturally decreases with age.