BioVie presents preliminary data on NE3107

BioVie announced that preliminary baseline data from its multicenter, randomized, placebo-controlled Phase 3 study of NE3107 in patients with mild to moderate Alzheimer’s Disease, AD, was presented as a poster at the American Neurological Association, ANA annual meeting, being held September 11-13, 2023 in Philadelphia, PA. The poster, Metabolic Dysregulation in Probable Alzheimer’s Disease, is being presented by Joseph Palumbo, Chief Medical Officer of BioVie, and highlights the preliminary baseline metabolic and inflammation characteristics from the Phase 3 study population. At baseline, the majority of the study population are coded with abdominal obesity, hypertension, and impaired glucose metabolism. Almost half of all patients are coded as having some degree of insulin resistance, 40% and 30% of patients are coded as having hypertriglyceridemia and hypercholesterolemia, respectively; and patients are coded as having elevated inflammatory markers. Since these are known dementia risk factors, the company believes NE3107’s potential ability to help patients improve on some of these factors, as shown in some prior clinical trials, suggests that it may help patients improve on cognitive metrics in this trial. Both Abeta+ and Abeta- patients with dementia were enrolled in the study and had, at baseline, comparable CDR-SB scores indicative of mild dementia. At baseline, enrolled Abeta+ patients had worse ADAS-Cog12 and MMSE scores, while the enrolled Abeta- patients had significantly higher inflammation, insulin resistance, IFG, and hypertension, compared to their Abeta+ counterparts. Subgroup analysis reveal higher degrees of impaired glucose metabolism and insulin resistance among the APOE 4- patients compared to their APOE 4+ counterparts and comparable baseline MMSE scores, indicating that both groups had mild to moderate cognitive impairment. Investigators in this study concluded that in the absence of classical risk markers, such as Abeta+ and APOE 4+, central obesity and age-related systems dysregulation, involving inflammation, hyperglycemia, insulin resistance, dyslipidemia, and hypertension, may contribute to probable AD and disease progression.