BioVie Inc (NASDAQ:BIVI) has issued a letter to shareholders providing an update on its progress and recent findings.
The letter highlights the company's excitement and optimism regarding the Phase 3 trial for NE3107 in Alzheimer's Disease (AD), which is expected to release its results later this year.
The letter reviews the Phase 2 exploratory biomarker study completed in 2022, which observed the impact of NE3107 treatment on 23 patients with moderate cognitive impairment (MCI) and mild AD. The study found that patients treated with NE3107 experienced enhanced cognition, reduced inflammation levels, decreased tau protein levels, improved brain regions, and reduced DNA methylation. No drug-related adverse events were observed.
During the recent Alzheimer's Association's International Conference held in Amsterdam, BioVie presented data showing that treatment with NE3107 resulted in significant reductions in DNA methylation. The treatment was found to reduce methylation levels of CpG probes associated with anti-inflammatory and antioxidant genes, insulin signaling, and neurostimulation. These reductions were correlated with improvements in cognition, biomarkers, and neuroimaging endpoints.
The company believes that the data suggests NE3107 may have the potential to reduce epigenetic changes driven by inflammation and improve neuronal health. These findings have implications for the ongoing Phase 3 trial for AD, which is expected to provide further insights into NE3107's effectiveness.
The letter also mentions data presented at the 83rd Scientific Sessions of the American Diabetes Association, which revealed that patients in the NM101 trial had elevated inflammatory markers and metabolic dysregulation. However, patients treated with NE3107 in previous trials showed improvements in these factors, providing additional optimism for the ongoing trial.
Based on the cumulative data and their understanding of NE3107's potential mechanisms of action, BioVie remains confident in the drug's ability to improve cognitive function and looks forward to the upcoming trial readout for confirmation.
The company believes that NE3107's broad and multisystem regulatory effect on inflammation, insulin signaling, and other critical biological processes can contribute to better neuronal health and cognitive improvement.
BioVie is a clinical-stage company specializing in drug therapies for neurological and neurodegenerative disorders and advanced liver disease.
Contact the author at jon.hopkins@proactiveinvestors.com