BioVie announces efficacy data from Phase 3 trial of NE3107

BioVie announced positive analysis of unblinded, topline efficacy data from its Phase 3 clinical trial of NE3107 in the treatment of mild to moderate Alzheimer’s Disease, AD. Data from evaluable patients show NE3107’s treatment advantage compared to placebo may be equal to or greater than the benefit from approved AD monoclonal antibodies. NE3107-treated patients also experienced a 4.66-year advantage in age deceleration vs. placebo as measured by epigenetics/DNA methylation Skin Blood Clock. Key Findings: Patients treated with NE3107 showed improved performance compared to placebo on all cognitive and functional assessments commonly used in the prior approval of amyloid beta-based AD therapies, although the data missed statistically significance due to site exclusions. Placebo-treated patients significantly worsened on virtually all assessments as expected from natural history of the disease. By contrast, NE3107-treated patients experienced a treatment advantage after 6 months that was equal to or greater than results reported from clinical trials for the approved Abeta monoclonal antibody treatments after 18 months. Improvements in Clinical Dementia Rating-Sum of Boxes among NE3107-treated patients appear correlated to changes in tumor necrosis factor alpha, plasma phosphorylated tau, and the ratio of Abeta42 to Abeta40. NE3107 appeared to decrease neuroinflammatory processes that link Neurofilament Light Chain and Glial fibrillary acidic protein, both considered biomarkers of neurodegeneration and cognitive decline. Patients treated with NE3107 saw an average of -5.66 years of age deceleration of the DNA methylation advantage compared to those on placebo. Age deceleration is the difference between the patient’s biological age as measured by the Horvath DNA methylation Skin Blood clock less the actual chronological age. NE3107 is believed to be the first drug candidate to demonstrate this impact on DNA methylation and the aging process in a double-blinded, placebo-controlled clinical.