BioVie Inc (NASDAQ:BIVI) said that blinded data presented at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston suggests its drug candidate, NE3107, may have a significant impact on cognitive, biomarker, and imaging endpoints in mild to moderate Alzheimer's Disease (AD) patients.
The findings from the recently completed Phase 3 clinical trial indicate NE3107 is a potential multi-mechanistic treatment for Alzheimer's, offering hope for patients dealing with the debilitating condition.
According to BioVie, statistically significant changes from baseline were observed in primary and secondary cognitive and functional assessments.
Additionally, an apparent reduction in amyloid burden was observed in the study population, as measured by the PrecivityAD test from C2N Diagnostics.
Changes from baseline were also observed in the Amyloid β 42/40 ratio and Amyloid Probability Score, as indicated by the PrecivityAD tests.
Increased FDG-PET SUVRs in brain imaging were observed in a sub-study, suggesting a potential reduction in amyloid burden, while statistically significant increases in insulin and beta cell function were observed without any hypoglycemia, supporting NE3107's potential mechanism of action.
BioVie told shareholders that data suggests that NE3107 is biologically active and may have a positive impact on cognitive and functional outcomes in AD patients.
Many patients showed improvements, contrary to the expected progression of the disease, which is typically marked by deterioration, BioVie said.
The data also indicated a significant reduction in amyloid burden, which is a significant biomarker in Alzheimer's disease.
Joseph Palumbo, BioVie's Chief Medical Officer, expressed optimism about these findings, indicating that the data shows "encouraging changes from baseline" that would not typically occur without a treatment effect.
The company is preparing to unblind the data, with expectations of announcing the topline results of this trial in late November or early December.